Cook, Inc.
Medical device manufacturer in Bloomington, IN.
364510(k) clearances
6PMA approvals
538recalls
Device types
- DQX Wire, Guide, Catheter 26
- DQY Catheter, Percutaneous 22
- FGE Stents, Drains And Dilators For The Biliary… 22
- DYB Introducer, Catheter 20
- DQO Catheter, Intravascular, Diagnostic 15
- KRA Catheter, Continuous Flush 14
- FAD Stent, Ureteral 13
- KRD Device, Vascular, For Promoting Embolization 13
- FOZ Catheter, Intravascular, Therapeutic… 13
- LIT Catheter, Angioplasty, Peripheral… 13
- LJS Catheter, Intravascular, Therapeutic… 9
- LJE Catheter, Nephrostomy 8
- MQF Catheter, Assisted Reproduction 7
- KNT Tubes, Gastrointestinal (And Accessories) 7
- JOH Tube Tracheostomy And Tube Cuff 6
- BWC Needle, Emergency Airway 6
- DTK Filter, Intravascular, Cardiovascular 6
- GEX Powered Laser Surgical Instrument 6
- JAK System, X-Ray, Tomography, Computed 6
- LQR Dislodger, Stone, Biliary 6
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K233177 | Nest VT Vitrification DeviceMQK · Traditional | 03/08/2024SE |
| K222254 | Gunther Tulip Vena Cava Filter Retrieval SetMMX · Traditional | 05/16/2023SE |
| K223098 | Bakri Essential Postpartum BalloonOQY · Special | 10/28/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | 04/06/2021SE |
| K203670 | Extra Large Check-Flo IntroducerDYB · Traditional | 02/16/2021SE |
| K191498 | Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…LJE · Traditional | 01/29/2020SESK |
| K190903 | Lawson Retrograde Nephrostomy Wire Puncture SetLJE · Traditional | 12/16/2019SE |
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi…JOH · Special | 12/12/2019SE |
| K191163 | Lumax Guiding CatheterDQY · Traditional | 12/12/2019SE |
| K190084 | McLean-Ring Enteral Feeding Tube SetKNT · Traditional | 10/11/2019SE |
| K183323 | UPJ Occlusion Balloon CatheterEYB · Traditional | 08/05/2019SESK |
| K182985 | Roadrunner PC Wire Guide, Olcott Torque DeviceDQX · Traditional | 07/22/2019SE |
| K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetLJE · Traditional | 07/16/2019SESK |
| K191485 | Deflectable Brush Biopsy SetFDX · Traditional | 06/26/2019SE |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetKGC · Traditional | 06/26/2019SESK |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterEYB · Traditional | 06/17/2019SESK |
| K182403 | Peel-Away IntroducerFED · Traditional | 05/29/2019SE |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…MQF · Special | 05/17/2019SE |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar NeedleLJE · Traditional | 05/17/2019SESK |
| K182252 | Cook Unimpregnated Central Venous CatheterFOZ · Traditional | 05/17/2019SE |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy SetFDX · Traditional | 05/01/2019SE |
| K182071 | Multi-Sideport Catheter Infusion SetKRA · Traditional | 04/25/2019SE |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent SetFAD · Traditional | 04/23/2019SESK |
| K182399 | Park Blade Septostomy CatheterDXF · Traditional | 04/04/2019SE |
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional | 03/29/2019SE |
| K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetLJE · Traditional | 03/27/2019SESK |
| K181722 | Polyethylene CatheterDQO · Traditional | 03/22/2019SE |
| K181353 | Lunderquist® Fixed Core Wire GuideDQX · Traditional | 02/15/2019SE |
| K181097 | Cook Cystostomy Catheter SetKOB · Traditional | 01/18/2019SESK |
| K183467 | Roadrunner Extra Support Wire GuideDQX · Special | 01/11/2019SE |
| K182709 | One-Step Suprapubic IntroducerKOB · Traditional | 12/26/2018SE |
| K183036 | Dilator SetsDRE · Traditional | 12/20/2018SE |
| K180830 | Reuter Tip Deflecting Wire GuideDQX · Traditional | 12/20/2018SE |
| K180846 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | 12/19/2018SESK |
| K180792 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | 11/30/2018SE |
| K180557 | Greene Renal Transplant Stent SetFAD · Traditional | 11/23/2018SE |
| K181757 | Günther Tulip® Vena Cava Filter Retrieval SetMMX · Traditional | 11/06/2018SE |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional | 10/30/2018SESK |
| K180300 | Margolin HSG Cannula, Goldstein Sonohysterography CatheterLKF · Traditional | 10/26/2018SE |
| K180291 | Cook Silicone Balloon HSG CatheterLKF · Traditional | 10/26/2018SE |
| K180286 | Polyethylene CatheterDQO · Traditional | 10/26/2018SE |
| K180302 | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator…MQF · Traditional | 10/24/2018SE |
| K180054 | Royal Flush Plus High-Flow CatheterDQO · Traditional | 10/05/2018SE |
| K180216 | Seidmon Antegrade AQ Stent SetFAD · Traditional | 09/28/2018SE |
| K180029 | Malecot Nephrostomy Catheter/Stent SetFAD · Traditional | 09/21/2018SE |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterEYB · Traditional | 09/14/2018SE |
| K180053 | Sof-Flex Ureteral Stent SetFAD · Traditional | 09/13/2018SE |
| K173657 | Radiance(TM) Clear Sharklet(R) Silicone Foley CatheterEZL · Traditional | 08/23/2018SE |
| K181713 | Ultraxx Nephrostomy Balloon Catheter SetLJE · Traditional | 08/17/2018SE |
| K181431 | Laser Ureteral CatheterGEX · Traditional | 07/30/2018SE |
| K181712 | San Antonio StopcockODC · Traditional | 07/26/2018SE |
| K173654 | Ureteral Dilator Sets, Ureteral DilatorsEZN · Traditional | 07/17/2018SE |
| K171272 | Cook-Swartz Doppler Flow ProbeITX · Traditional | 07/17/2018SE |
| K180552 | Modified Novy Cornual Cannulation SetMOV · Special | 07/12/2018SE |
| K181144 | Angled Tip Ureteral CatheterKOD · Traditional | 06/28/2018SE |
| K173414 | Advance Biliary Balloon CatheterGCA · Traditional | 06/22/2018SESK |
| K181351 | Double Flexible Tipped Wire GuidesDQX · Special | 06/14/2018SE |
| K173155 | Pakter Curved Needle SetBSP · Traditional | 06/07/2018SE |
| K171609 | Check-Flo Performer Introducer Micropuncture Radial Artery Access SetDYB · Traditional | 06/04/2018SE |
| K180756 | Safety Wire Guide IntroducerEZN · Traditional | 05/24/2018SE |
| K180034 | Weinmann Tracheostomy Exchange SetJOH · Traditional | 05/07/2018SE |
| K172980 | Micropuncture Pedal Access SetDYB · Traditional | 05/03/2018SE |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer SetEZN · Traditional | 05/02/2018SE |
| K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter…FGE · Traditional | 05/01/2018SE |
| K171917 | Frova Intubating IntroducerBTR · Traditional | 04/23/2018SE |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator SetEZN · Traditional | 04/19/2018SESK |
| K171603 | Cope Nephroureterostomy Stent and Amplatz Ureteral Stent SetFAD · Traditional | 04/16/2018SESK |
| K173103 | Pivet and Soft-Pass Embryo Transfer Catheter SetsMQF · Traditional | 04/13/2018SE |
| K173686 | Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer CatheterMQF · Traditional | 04/11/2018SE |
| K172635 | High-Flo Silver Polyethylene CatheterDQO · Traditional | 04/03/2018SE |
| K171997 | Mandril Wire GuideDQX · Traditional | 03/30/2018SE |
| K171988 | Performer Guiding SheathDYB · Traditional | 03/30/2018SE |
| K172017 | Black Silicone Filiform Double Pigtail Stent SetFAD · Traditional | 03/26/2018SESK |
| K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterODC · Traditional | 03/22/2018SE |
| K171912 | Double Flexible Tip Wire GuidesDQX · Traditional | 03/19/2018SE |
| K171820 | Transjugular Liver Access SetsDYB · Traditional | 03/09/2018SE |
| K171764 | Fixed Core Wire GuidesDQX · Traditional | 03/09/2018SE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional | 03/07/2018SE |
| K171915 | Nathanson Transcystic Bile Duct Stone Exploration PackLQR · Traditional | 03/01/2018SE |
| K171601 | Ultraxx Nephrostomy Balloon CatheterLJE · Traditional | 02/23/2018SE |
| K171994 | Silicone Peripherally Inserted Central Venous Catheter Set/TrayLJS · Traditional | 02/22/2018SE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional | 02/16/2018SE |
| K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set…LKF · Traditional | 02/15/2018SE |
| K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End…KOD · Traditional | 02/01/2018SE |
| K171264 | Royal Flush CatheterDQO · Traditional | 01/25/2018SE |
| K172051 | Guardia Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo…MQF · Traditional | 01/10/2018SE |
| K171445 | Amplatz Support Wire Guide with Apex CurveDQX · Traditional | 01/10/2018SE |
| K171948 | Roadrunner Extra Support Wire GuideDQX · Special | 01/05/2018SE |
| K172321 | Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersMQF · Special | 12/21/2017SE |
| K173685 | Peel-Away Introducer SetDYB · Special | 12/20/2017SE |
| K171275 | Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…DYB · Special | 12/20/2017SESK |
| K173687 | Strange Bile Duct Stone Exploration SetLQR · Traditional | 12/15/2017SESK |
| K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathFED · Traditional | 12/13/2017SE |
| K170898 | Wittich Nitinol Stone BasketLQR · Traditional | 12/12/2017SE |
| K172278 | Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentGBM · Traditional | 11/22/2017SE |
| K173355 | Gastric Sizing Balloon CatheterKNT · Special | 11/17/2017SESK |
| K173068 | Performer IntroducerDYB · Traditional | 11/17/2017SE |
| K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle…DQO · Special | 11/15/2017SE |
| K170931 | CXI TriForce Peripheral Crossing SetKRA · Special | 11/13/2017SE |
| K173009 | NCompass Nitinol Stone ExtractorsLQR · Traditional | 11/07/2017SE |
| K172325 | Rhapsody H-30 Holmium Laser SystemGEX · Traditional | 10/26/2017SE |
| K172527 | Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz…LJE · Traditional | 10/19/2017SE |
| K170298 | Liberator Beacon Tip Locking StyletDRB · Traditional | 10/18/2017SE |
| K170020 | Peel-Away Introducer SetDYB · Traditional | 09/28/2017SE |
| K170323 | Entuit Start Initial Placement Gastrostomy SetKGC · Traditional | 09/14/2017SE |
| K170010 | Salle Intraoperative Pyeloplasty Stent SetFAD · Traditional | 08/28/2017SE |
| K171853 | Liver Access and Biopsy SetsDYB · Traditional | 08/24/2017SE |
| K171897 | Approach CTO Microwire GuideDQX · Traditional | 08/21/2017SE |
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange…BSR · Traditional | 08/11/2017SE |
| K171999 | Performer IntroducerDYB · Special | 07/31/2017SE |
| K171602 | Williams Cystoscopic Injection NeedleFBK · Traditional | 07/28/2017SE |
| K163031 | Bunegin-Albin Air Aspiration SetDXE · Traditional | 07/27/2017SE |
| K163318 | Soules Intrauterine Insemination CatheterMQF · Traditional | 07/14/2017SE |
| K163353 | Needle's Eye Snare Retrieval Set - 54cmDXE · Special | 07/11/2017SE |
| K162109 | Kwart Retro-Inject Ureteral StentFAD · Traditional | 06/07/2017SE |
| K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterDQO · Traditional | 05/26/2017SE |
| K170603 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 05/24/2017SE |
| K163197 | Cook Holmium Laser FiberGEX · Traditional | 05/24/2017SE |
| K160567 | Barone Jejunostomy Catheter SetKNT · Traditional | 05/18/2017SE |
| K160509 | Tiger 2 Self-Advancing Nasal Jejunal Feeding TubeKNT · Traditional | 05/18/2017SESK |
| K170616 | van Andel Dilatation CatheterDRE · Traditional | 04/28/2017SE |
| K162104 | C-Flex Ureteral Stent SetFAD · Traditional | 04/24/2017SESK |
| K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentOQY · Special | 03/31/2017SE |
| K170008 | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle SetKNW · Traditional | 02/28/2017SE |
| K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy…BWC · Traditional | 02/17/2017SE |
| K170193 | Advance 14LP Low Profile PTA Balloon Dilatation CatheterLIT · Special | 02/13/2017SE |
| K161236 | Universa Firm Ureteral Stents and Stent SetsFAD · Traditional | 01/27/2017SE |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayMPB · Special | 01/06/2017SEKD |
| K160884 | CXI Support CatheterKRA · Special | 11/22/2016SE |
| K161822 | Torcon NB Advantage CathetersDQO · Special | 10/27/2016SE |
| K161496 | Turbo-Flo PICC SetsLJS · Traditional | 10/07/2016SE |
| K160217 | uVue HSG/SHG CatheterLKF · Traditional | 10/06/2016SE |
| K161002 | Aprima Smartesis Centesis PumpBTA · Traditional | 09/28/2016SE |
| K153761 | Emergency Transtracheal Airway CatheterBWC · Traditional | 09/22/2016SE |
| K160593 | Indy OTW Vascular RetrieverMMX · Traditional | 09/02/2016SE |
| K160219 | Hilal Embolization MicroCoilsKRD · Traditional | 08/03/2016SE |
| K160542 | 5.0 Fr Arndt Endobronchial Blocker SetCBI · Special | 08/02/2016SE |
| K161801 | CrossCath Support CatheterKRA · Special | 07/29/2016SE |
| K160887 | Cook Intraosseous Infusion NeedlesFMI · Special | 07/26/2016SE |
| K161218 | Gianturco-Roehm Birds Nest Vena Cava FilterDTK · Traditional | 07/22/2016SE |
| K160891 | Ultrathane Endoureterotomy Stent SetFAD · Traditional | 06/24/2016SE |
| K153778 | Nester Embolization Coils, Tornado Embolization CoilsKRD · Traditional | 05/19/2016SE |
| K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic…NHC · Special | 04/08/2016SE |
| K153430 | Flexor Tuohy-Borst Side-Arm Introducers Shuttle SelectDYB · Special | 03/07/2016SE |
| K151051 | Universa Soft Ureteral Stents and Stent SetsFAD · Traditional | 01/11/2016SE |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteMQH · Traditional | 01/08/2016SE |
| K150964 | MReye Flipper Detachable Embolization Coil and Delivery SystemKRD · Traditional | 12/18/2015SE |
| K150931 | MReye Embolization CoilsKRD · Traditional | 12/18/2015SE |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation PipetteMQH · Traditional | 12/18/2015SE |
| K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable…FGE · Special | 09/30/2015SE |
| K152044 | Flexor Radial Hydrophilic Introducer Access SetDYB · Special | 08/14/2015SE |
| K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…DYB · Traditional | 07/28/2015SE |
| K142819 | Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer SetDYB · Traditional | 07/24/2015SE |
| K151676 | Retracta Detachable Embolization CoilKRD · Special | 07/22/2015SE |
| K150802 | Heavy Double Flexible Tipped Wire GuideDQX · Traditional | 05/28/2015SE |
| K150733 | Vital-Port Vascular Access System Power Injectable PortLJT · Special | 05/21/2015SE |
| K150970 | Coda LP Balloon CatheterDQY · Special | 05/12/2015SE |
| K141322 | Advance Enforcer 35 Focal Force Pta Balloon CatheterPNO · Traditional | 03/27/2015SE |
| K133788 | Cook Holmium Laser FiberGEX · Traditional | 03/18/2015SE |
| K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterDQO · Traditional | 01/09/2015SE |
| K140593 | Advance Salivary Balloon Catheter with Wire GuideGCJ · Traditional | 12/15/2014SE |
| K140085 | Universa Percultaneous Drainage CatheterFEW · Traditional | 11/18/2014SE |
| K132592 | Flexor Radial Hydrophilic Introducer Access SetDYB · Traditional | 10/09/2014SE |
| K133114 | Micropuncture Introducer SetDYB · Traditional | 07/03/2014SE |
| K140169 | Vital-Port(R) CT Vascular Access SystemLJT · Traditional | 05/21/2014SE |
| K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…JOH · Traditional | 04/18/2014SE |
| K131772 | Cantata(R) 2.9 MicrocatheterKRA · Traditional | 02/20/2014SE |
| K131204 | Advance CS Coronary Sinus Infusion CatheterDQY · Traditional | 01/29/2014SE |
| K133634 | Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter SetLJS · Special | 12/23/2013SE |
| K132020 | Advance 34LP Low Profile Pta Balloon Dilatation CatheterLIT · Special | 10/25/2013SE |
| K132885 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetLJS · Special | 10/11/2013SE |
| K131201 | Entuit Secure Gastrointestional Suture Anchor Set, Entuit Secure Adjustable…FGE · Traditional | 10/07/2013SE |
| K131206 | Cook Cervical Ripening BalloonPFJ · Traditional | 09/27/2013SE |
| K132334 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) SetLJS · Special | 08/16/2013SE |
| K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…MPB · Traditional | 07/29/2013SESK |
| K130766 | Roadrunner Uniglide Hydrophilic Wire GuideDQX · Special | 07/17/2013SE |
| K124030 | Cook Holmium Laser FiberGEX · Special | 07/01/2013SE |
| K122917 | Coda Balloon CatheterDQY · Special | 06/28/2013SE |
| K130293 | Advance 18LP Low Profile Pta Balloon Dilatation CatheterLIT · Special | 05/31/2013SE |
| K130444 | H-30 Holmium Laser SystemGEX · Special | 05/22/2013SE |
| K122940 | Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3DQY · Traditional | 03/19/2013SE |
| K123707 | Alight 16 Superselective Microwire GuideDQX · Special | 02/28/2013SE |
| K123235 | Equaflow Multivalve Infusion CatheterDYB · Traditional | 02/14/2013SE |
| K123712 | Retracta Detachable Embolization CoilKRD · Special | 01/03/2013SE |
| K122937 | Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath…DQO · Special | 12/14/2012SE |
| K122796 | Cxi Support CatheterKRA · Special | 10/11/2012SE |
| K120468 | Ncircle(R) Nitinol Tipless Stone Extractor Ngage(R) Nitinol Stone ExtractorGCJ · Traditional | 07/06/2012SE |
| K113300 | Atb Advance Pta Dilatation CatheterLIT · Special | 12/09/2011SE |
| K112185 | Foursnare Vascular Retrieval SnareMMX · Traditional | 11/02/2011SE |
| K111263 | Cxi TriforceKRA · Traditional | 07/25/2011SE |
| K111244 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)LJS · Special | 06/14/2011SE |
| K110163 | Approach Pro ST Wire GuideDQX · Special | 02/25/2011SE |
| K110009 | Roadrunner Uniglide Hydrophilic Wire GuideDQX · Special | 02/02/2011SE |
| K101450 | Cantata MicrocatheterKRA · Special | 12/30/2010SE |
| K101728 | Focus (TM) Echogenic Nerve Stimulating NeedleBSP · Special | 08/25/2010SE |
| K101877 | Occlusion Balloon Catheter Model ObcDQY · Special | 08/06/2010SE |
| K100974 | Spectrum Turbo-Ject Picc SetFOZ · Special | 05/06/2010SE |
| K100283 | Versatube Tapered Tracheostomy Tube with Disposable Inner Cannula, Multiple, Prefixes…BTO · Traditional | 04/23/2010SE |
| K093209 | Focus ( TM) Echogenic Nerve Stimulating NeedleBSP · Traditional | 02/26/2010SE |
| K093469 | Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer, Model: Multiple…JOH · Special | 01/08/2010SE |
| K093052 | Crosscath Support CathterKRA · Traditional | 12/08/2009SE |
| K091385 | Approach Hydro ST Wire Guide, Model HMWDQX · Special | 08/07/2009SE |
| K091527 | Advance 35LP Low Profile Pta Balloon Dilatation CatheterDQY · Special | 06/12/2009SE |
| K090822 | Advance 14RX Rapid Exchange Pta Balloon CatheterDQY · Special | 04/27/2009SE |
| K090624 | Cook Mreye Embolization CoilsKRD · Special | 04/02/2009SE |
| K090133 | Connex Gastrointestinal Suture Anchor, Model GiasFGE · Special | 02/20/2009SE |
| K081768 | Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesNAJ · Traditional | 12/23/2008SE |
| K081337 | Approach Cto Wire GuideDQX · Special | 08/08/2008SE |
| K080737 | Miraflex High Flow MicrocatheterKRA · Special | 08/08/2008SE |
| K080037 | Modification to Zilver 635 Biliary StentFGE · Traditional | 08/01/2008SESU |
| K081113 | Cook and Cook Spectrum Central Venous CathetersFOZ · Traditional | 07/30/2008SE |
| K081690 | Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterFOZ · Special | 07/14/2008SE |
| K073627 | Flexor Evac Aspiration CatheterQEZ · Traditional | 03/04/2008SE |
| K073528 | Vena Cava FilterDTK · Special | 02/27/2008SE |
| K073378 | Advance 18LP Pta Dilatation CatheterDQY · Special | 12/28/2007SE |
| K072625 | Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)LJS · Traditional | 12/13/2007SE |
| K072724 | Cxi Support CatheterKRA · Special | 11/09/2007SE |
| K072240 | Gunther Tulip Vena Cava FilterDTK · Special | 11/08/2007SE |
| K072148 | Ciaglia Blue Dolphin (TM) Balloon Percutaneous Tracheostomy IntroducerJOH · Special | 10/03/2007SE |
| K071640 | Ventriclear II, Spectrum Ventricular Drainage Catheter, Model N-VVDC-02-ABRMNHC · Special | 07/12/2007SE |
| K070410 | Cook Microwire Wire GuideDQX · Special | 04/27/2007SE |
| K063619 | Flipper Detachable Embolization CoilsKRD · Special | 12/20/2006SE |
| K063252 | Atb Advanced Pta Dilatation CatheterDQY · Special | 11/14/2006SE |
| K060224 | Modification to Mira-Flex 18 MicrocatheterKRA · Special | 03/06/2006SE |
| K060174 | Spectrum Five Lumen Central Venous Catheter Set, Model C-UQLM10.0-ABRMFOZ · Special | 02/17/2006SE |
| K052539 | Cook Formula 418 Biliary Stent SystemFGE · Special | 12/09/2005SE |
| K052841 | Mira-Flex 18 MicrocatheterKRA · Special | 12/08/2005SE |
| K052834 | Mreye Embolization CoilKRD · Traditional | 11/23/2005SE |
| K042691 | Vertefix Vertebroplasty Procedure SetNDN · Traditional | 11/08/2005SE |
| K052036 | Atb Advance Pta Dilatation CatheterDQY · Special | 08/25/2005SE |
| K051785 | Formula 418 Biliary StentFGE · Traditional | 08/23/2005SESU |
| K041849 | Turbo-Flo PiccLJS · Traditional | 07/21/2005SESU |
| K051124 | Zilver 635 Biliary StentFGE · Special | 07/12/2005SESU |
| K043509 | Gunther Tulip Vena Cava Filter SetDTK · Special | 05/05/2005SE |
| K050698 | Modification To:Zilver 518 Biliary StentFGE · Special | 03/30/2005SE |
| K043481 | Modification to: Zilver 635 Biliary StentFGE · Special | 12/29/2004SESU |
| K042611 | Lunderquist Extra Stiff Double Curved Exchange Wire GuideDQX · Special | 11/12/2004SE |
| K042518 | Zilver 518 Biliary StentFGE · Special | 10/01/2004SE |
| K033843 | Spectrum Central Venous Catheter with or Without Hydrophilic CoatingFOZ · Traditional | 08/12/2004SE |
| K041044 | Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetJOH · Traditional | 07/29/2004SE |
| K033875 | Atb All-Terrain Balloon Pta Dilatation CatheterDQY · Traditional | 04/02/2004SE |
| K040505 | Zilver 635 Biliary StentFGE · Special | 03/16/2004SESU |
| K032274 | Cook Five Lumen Central Venous CatheterFOZ · Traditional | 02/26/2004SE |
| K033348 | Zilver 518 Biliary StentFGE · Special | 12/15/2003SESU |
| K032869 | Cook Coda Balloon CatheterDQY · Traditional | 11/19/2003SE |
| K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetDTK · Traditional | 10/31/2003SE |
| K032931 | Pta Balloon CatheterDQY · Special | 10/22/2003SE |
| K031966 | Enk Fiberoptic Atomizer SetEOQ · Traditional | 10/16/2003SESU |
| K031821 | Modification to Cook Zilver Biliary StentFGE · Special | 07/18/2003SESU |
| K030841 | Cook Gastric Sizing Balloon CatheterKNT · Traditional | 07/11/2003SE |
| K031766 | Atb All-Terrain Balloon Pta Dilatation CatheterDQY · Special | 06/26/2003SE |
| K021557 | Spectrum Silicone CatheterFOZ · Traditional | 05/30/2003SE |
| K023504 | Modification to Atb All-Terrain Balloon Pta Dilatation CatheterLIT · Special | 11/13/2002SE |
| K022552 | Atb All-Terrain Balloon Pta Dilatation CatheterDQY · Special | 09/27/2002SE |
| K021920 | 7.0 Fr. Endobronchial BlockerCBI · Special | 08/14/2002SE |
| K013182 | Triple Lumen Central Venous CatheterFOZ · Traditional | 07/01/2002SE |
| K013865 | Tip Deflrcting Endobronchial BlockerCBI · Special | 04/22/2002SE |
| K013252 | Patil Emergency Cricothyrotomy Catheter SetBWC · Traditional | 02/21/2002SE |
| K013241 | Arndt Emergency Cricothyrotomy Catheter SetBWC · Traditional | 02/21/2002SE |
| K013916 | Melker Emergency Cricothyrotomy Catheter SetBWC · Traditional | 12/20/2001SE |
| K010601 | Fanelli Biliary StentFGE · Traditional | 11/16/2001SE |
| K011812 | Spectrum Ventricular CatheterNHC · Traditional | 11/08/2001SE |
| K010016 | Melker Cuffed Emergency Cricothyrotomy CatheterBWC · Traditional | 10/09/2001SE |
| K010450 | Liver Tamponade BalloonNGU · Traditional | 09/06/2001SE |
| K010242 | Cook Zilver Biliary StentFGE · Traditional | 08/13/2001SESU |
| K002286 | Ldob Occlusion Balloon CatheterMJN · Traditional | 03/22/2001SE |
| K002254 | Cook Pressure Monitoring CatheterDQO · Traditional | 03/16/2001SE |
| K001985 | Introdeuce Double Lumen IntroducerDYB · Traditional | 01/25/2001SE |
| K010034 | Double Lumen Urethane Picc Line, Model Upicds-FOZ · Special | 01/24/2001SE |
| K002288 | Arndt Pediatric Endobronchial BlockerCBI · Traditional | 11/28/2000SE |
| K000651 | Detach 18 and Detach 11, Neurological Embolization Coil SystemHCG · Traditional | 11/24/2000SE |
| K000855 | Gunther Tulip Vena Cava Mreye Filter SetDTK · Traditional | 10/18/2000SE |
| K001087 | Pta Balloon CatheterLIT · Special | 07/20/2000SE |
| K993455 | Flipper Detachable Embolization CoilKRD · Traditional | 01/11/2000SE |
| K992121 | Embolization Coil SystemKRD · Traditional | 12/20/1999SE |
| K992198 | Urethane Picc Line Model Upics-FOZ · Special | 08/27/1999SE |
| K991985 | Cook High Volume Infusion Adapter Intravascular Administration SetFPA · Traditional | 08/20/1999SE |
| K990753 | Grac High Dose Rate (HDR) Remote Afterloading CatheterJAQ · Traditional | 05/27/1999SE |
| K990726 | Envy Guiding CatheterDQY · Special | 04/02/1999SE |
| K982333 | Modification to Uldall Double Lumen Hemodialysis Catheter Set and TrayMSD · Traditional | 02/12/1999SE |
| K982500 | Chait Cecostomy CatheterKNT · Traditional | 01/27/1999SE |
| K983217 | Rowe Dual-Check ValveFPA · Traditional | 01/20/1999SE |
| K983771 | Strategy Coronary Wire GuideDQX · Special | 11/12/1998SE |
| K981886 | Vrac High Dose Rate (HDR) Remote Afterloading CatheterJAQ · Traditional | 11/03/1998SE |
| K974774 | Envy Guiding CatheterDQO · Traditional | 10/16/1998SE |
| K980390 | Pta Balloon CatheterLIT · Traditional | 08/20/1998SE |
| K981906 | Modification for Pta Balloon CatheterLIT · Special | 06/29/1998SE |
| K972800 | Pta Balloon CatheterLIT · Traditional | 04/16/1998SE |
| K973565 | Quick-Care Biopsy NeedleKNW · Traditional | 11/03/1997SE |
| K962167 | Bronchial BlockerCBI · Traditional | 08/29/1997SE |
| K963565 | MRI NeedlesFCG · Traditional | 07/14/1997SE |
| K961668 | Microferret CatheterKRA · Traditional | 11/04/1996SE |
| K962761 | Reigel Tunneling DeviceGYK · Traditional | 10/11/1996SE |
| K962097 | Ventricular Catheter SetJXG · Traditional | 08/29/1996SE |
| K950118 | Abrm CatheterFOZ · Traditional | 02/08/1996SE |
| K940973 | Mullan Ganglion Microcompression SetHAO · Traditional | 09/29/1995SE |
| K945201 | Coverd Gianturco-Rosch Esophageal Z-StentESW · Traditional | 01/04/1995SE |
| K940189 | Coil Positioner SetKRD · Traditional | 11/28/1994SE |
| K940982 | Arterial Embolization Device (KRD)KRD · Traditional | 10/14/1994SE |
| K940550 | Cook Brach Needle/Radio Deliv Cath/Flexi FlexicathIWJ · Traditional | 08/17/1994SE |
PMA approvals
- P020018 Zenith Aaa Endovascular Graft and H&L-B One-Shot Introductino System · 05/23/2003 · 64 supplements
- P990008 Cook MBC Ptca Balloon Dilatation Catheter · 09/27/1999 · 0 supplements
- P900007 Cook Chorionic Villus Sampling Set · 09/30/1994 · 5 supplements
- P910030 Gianturco-Roubin Coronary Flex-Stent(Tm) · 02/08/1993 · 6 supplements
- P880078 VH8500 Hyperthermia Treatment System · 10/17/1989 · 10 supplements
- P850049 Cook Bird's Nest Vena Cava Filter · 04/26/1989 · 9 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-1936-2026 Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | 04/02/2026Open, Classified |
| Z-1935-2026 Class I | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | 04/02/2026Open, Classified |
| Z-1934-2026 Class I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | 04/02/2026Open, Classified |
| Z-1792-2026 Class II | COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1791-2026 Class II | COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1790-2026 Class II | COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1789-2026 Class II | COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1788-2026 Class II | COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1787-2026 Class II | COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1786-2026 Class II | COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1785-2026 Class II | Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1784-2026 Class II | COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1783-2026 Class II | COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1782-2026 Class II | COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1781-2026 Class II | COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1780-2026 Class II | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1779-2026 Class II | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1778-2026 Class II | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1777-2026 Class II | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1776-2026 Class II | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1775-2026 Class II | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-0995-2026 Class II | Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | 11/26/2025Open, Classified |
| Z-0994-2026 Class II | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2)…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | 11/26/2025Open, Classified |
| Z-0993-2026 Class II | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1)…Cook Medical identified that products supplied in the affected device lots may have been manufactured out of… | 11/26/2025Open, Classified |
| Z-1902-2025 Class I | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and…Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. | 05/15/2025Open, Classified |
| Z-1787-2025 Class II | Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF…Cook Medical identified that devices from the affected device lots may contain the incorrectly sized… | 04/17/2025Open, Classified |
| Z-1786-2025 Class II | Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF…Cook Medical identified that devices from the affected device lots may contain the incorrectly sized… | 04/17/2025Open, Classified |
| Z-1762-2025 Class II | Tornado Embolization Microcoil, intended for embolization of selective vessel supply to…Cook Medical identified that devices from the affected device lots may contain the incorrectly sized… | 04/17/2025Open, Classified |
| Z-0499-2025 Class II | Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789Devices from the affected device lots have labels that state the incorrect expiration dates. | 10/14/2024Open, Classified |
| Z-0347-2025 Class II | Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers:…Affected device lots have labels that state the incorrect expiration dates. | 10/08/2024Open, Classified |
| Z-0346-2025 Class II | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers:…Affected device lots have labels that state the incorrect expiration dates. | 10/08/2024Open, Classified |
| Z-0045-2025 Class II | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number…Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the… | 09/16/2024Open, Classified |
| Z-2223-2024 Class II | Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage…Product labels state the incorrect expiration dates that extends beyond their true expiration date | 05/15/2024Open, Classified |
| Z-2222-2024 Class II | Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter…Product labels state the incorrect expiration dates that extends beyond their true expiration date | 05/15/2024Open, Classified |
| Z-1532-2024 Class II | Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1531-2024 Class II | Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1530-2024 Class II | Dilator - Intended to be used for dilating puncture sites or catheter tracts for…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1529-2024 Class II | Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1528-2024 Class II | Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1527-2024 Class II | Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1526-2024 Class II | Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1525-2024 Class II | Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 03/01/2024Open, Classified |
| Z-1428-2023 Class I | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers…There were reports from customers that the tracheostomy in the sets and trays is not making a secure… | 04/07/2023Open, Classified |
| Z-1427-2023 Class I | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers…There were reports from customers that the tracheostomy in the sets and trays is not making a secure… | 04/07/2023Open, Classified |
| Z-1847-2022 Class II | Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1846-2022 Class II | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1845-2022 Class II | Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1844-2022 Class II | Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1843-2022 Class II | Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1842-2022 Class II | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1841-2022 Class II | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1840-2022 Class II | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1839-2022 Class II | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1838-2022 Class II | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1837-2022 Class II | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1836-2022 Class II | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1835-2022 Class II | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1834-2022 Class II | Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1833-2022 Class II | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1832-2022 Class II | Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1831-2022 Class II | Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1830-2022 Class II | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1829-2022 Class II | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1828-2022 Class II | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1827-2022 Class II | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1826-2022 Class II | Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1825-2022 Class II | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip)…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1824-2022 Class II | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | 08/16/2022Open, Classified |
| Z-1718-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1717-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1716-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1715-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1714-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1713-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1712-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1711-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1710-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1709-2022 Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1708-2022 Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1707-2022 Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1706-2022 Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | 07/19/2022Open, Classified |
| Z-1362-2022 Class II | Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250…The products may contain excess coating material on the outside and/or interior of the needle component.… | 05/25/2022Completed |
| Z-1242-2022 Class II | Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO…The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | 05/05/2022Open, Classified |
| Z-1241-2022 Class II | Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER…The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | 05/05/2022Open, Classified |
| Z-1240-2022 Class II | Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN…The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | 05/05/2022Open, Classified |
| Z-0388-2022 Class II | Flexor Check-Flo Introducer Ansel Modification Model Number:…Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may… | 11/12/2021Terminated |
| Z-0387-2022 Class II | Flexor Check-Flo Introducer Ansel Modification Model Number:…Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may… | 11/12/2021Terminated |
| Z-0414-2022 Class II | Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle…Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the… | 10/13/2021Open, Classified |
| Z-0223-2022 Class II | Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set…Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be… | 10/08/2021Terminated |
| Z-0222-2022 Class II | Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product…Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be… | 10/08/2021Terminated |
| Z-0186-2022 Class II | Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN…Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the… | 09/28/2021Terminated |
| Z-0185-2022 Class II | Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The…Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the… | 09/28/2021Terminated |
| Z-0960-2021 Class II | Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde…Manufactured with incorrect material, which may result in the stent being stiffer and potentially… | 01/04/2021Terminated |
| Z-0611-2021 Class I | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0610-2021 Class I | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0609-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0608-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0607-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0606-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0605-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0604-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0603-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0602-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0601-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0600-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0599-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0598-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0597-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0596-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0595-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0594-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0593-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0592-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0591-2021 Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor…There is an increased likelihood of the introducer sheath separating at the proximal bond site. If… | 11/24/2020Terminated |
| Z-0399-2021 Class I | Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide…Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence… | 10/22/2020Terminated |
| Z-0106-2021 Class II | Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order…The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set… | 08/31/2020Terminated |
| Z-0105-2021 Class II | Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order…The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set… | 08/31/2020Terminated |
| Z-2964-2020 Class II | Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the…May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy… | 08/11/2020Terminated |
| Z-2971-2020 Class II | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526…Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm… | 07/30/2020Terminated |
| Z-2546-2020 Class II | Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is…Identified products may contain a damaged bushing within the delivery system, which could potentially result… | 06/02/2020Terminated |
| Z-2204-2020 Class II | Pressure Monitoring Tray, C-PMSY, G02854The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of… | 04/30/2020Terminated |
| Z-2203-2020 Class II | Pressure Monitoring Set, C-PMS, G02838The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of… | 04/30/2020Terminated |
| Z-1940-2020 Class II | Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN)…The firm received complaints on five devices from one specific lot where the stent dislodged from the… | 04/15/2020Terminated |
| Z-1566-2020 Class II | Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number…The printed expiration dates are incorrect. | 03/06/2020Terminated |
| Z-1565-2020 Class II | Pericardiocentesis Set, Irrigation Catheter, Reference Part Number…The printed expiration dates are incorrect. | 03/06/2020Terminated |
| Z-1355-2020 Class II | Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an…The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen… | 01/16/2020Terminated |
| Z-0815-2020 Class II | Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL…Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could… | 12/27/2019Terminated |
| Z-0590-2020 Class I | CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | 11/08/2019Terminated |
| Z-0589-2020 Class I | CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | 11/08/2019Terminated |
| Z-0588-2020 Class I | CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | 11/08/2019Terminated |
| Z-0587-2020 Class I | CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For…A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath… | 11/08/2019Terminated |
| Z-0491-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0490-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0489-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0488-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0487-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0486-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0485-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0484-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0483-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0482-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0481-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0480-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0479-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0478-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0477-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0476-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0475-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0474-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0473-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0472-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0471-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0470-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0469-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0468-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0467-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0466-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0465-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0464-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0463-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0462-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0461-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0460-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0459-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0458-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0457-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0456-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0455-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0454-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0453-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0452-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0451-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0450-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0449-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0448-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0447-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0446-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0445-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0444-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0443-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0442-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0441-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0440-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0439-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0438-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0437-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0436-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0435-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0434-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0433-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0432-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0431-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0430-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0429-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0428-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0427-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0426-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0425-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0424-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |
| Z-0423-2020 Class II | Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and…The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches… | 10/21/2019Terminated |