Teleflexmedical, Inc.
Medical device manufacturer in Morrisville, NC.
64510(k) clearances
0PMA approvals
0recalls
Device types
- BTR Tube, Tracheal (W/Wo Connector) 5
- GCJ Laparoscope, General & Plastic Surgery 5
- DYB Introducer, Catheter 4
- EZL Catheter, Retention Type, Balloon 4
- GAT Suture, Nonabsorbable, Synthetic… 4
- CAF Nebulizer (Direct Patient Interface) 4
- DQX Wire, Guide, Catheter 3
- MSD Catheter, Hemodialysis, Implanted 3
- CAC Apparatus, Autotransfusion 3
- CBN Apparatus, Gas-Scavenging 3
- CAZ Anesthesia Conduction Kit 2
- GEI Electrosurgical, Cutting & Coagulation &… 2
- FZP Clip, Implantable 2
- BTT Humidifier, Respiratory Gas, (Direct… 2
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 2
- OCW Endoscopic Tissue Approximation Device 2
- JOH Tube Tracheostomy And Tube Cuff 2
- FAT Bougie, Esophageal, And Gastrointestinal… 1
- BWF Spirometer, Therapeutic (Incentive) 1
- FOZ Catheter, Intravascular, Therapeutic… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | 08/01/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | 07/27/2023SE |
| K192324 | Sheridan Spiral-Flex Endotracheal TubesBTR · Traditional | 12/06/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | 07/01/2019SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | 05/24/2019SE |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent…GBM · Traditional | 05/08/2019SESK |
| K181852 | Percuvance Percutaneous Surgical SystemGEI · Traditional | 10/12/2018SE |
| K173280 | Neonatal ConchaSmart Breathing CircuitsBZE · Traditional | 08/02/2018SE |
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleOCW · Traditional | 02/12/2018SE |
| K161770 | Rusch Silicone Foley CatheterEZL · Traditional | 05/05/2017SE |
| K162522 | UltraCath Continuous Nerve block CatheterBSO · Traditional | 03/17/2017SE |
| K162989 | Rusch Simplastic Foley CathetersEZL · Traditional | 02/24/2017SE |
| K162242 | Comfort Flo Humidification SystemBTT · Traditional | 01/19/2017SE |
| K162396 | SILK Surgical SutureGAP · Traditional | 11/23/2016SE |
| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | 10/04/2016SE |
| K153089 | 'cottony' II TAPE, PLEDGETSGAT · Traditional | 08/12/2016SE |
| K153010 | Hudson RCI AquaPak Sterile Prefilled NebulizersCAF · Traditional | 07/26/2016SE |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…GAT · Traditional | 06/16/2016SE |
| K153063 | Percuvance Percutaneous Surgical SystemGEI · Traditional | 04/08/2016SE |
| K150603 | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal TubeBTR · Traditional | 11/27/2015SE |
| K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierFZP · Special | 08/26/2015SE |
| K143581 | Arrow Epidural Catheter KitCAZ · Traditional | 06/26/2015SE |
| K142103 | Cuff Pilot, Sure SealBSK · Traditional | 05/08/2015SE |
| K142153 | Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLCAF · Traditional | 04/29/2015SE |
| K141888 | Rusch Endobronchial TubesCBI · Traditional | 04/15/2015SE |
| K150438 | Force Fiber OrthoTape sutureGAT · Special | 04/02/2015SE |
| K143469 | SOFTECH Plus ETCO2 CannulaCCK · Special | 02/12/2015SE |
| K143299 | Percuvance(R) Percutaneous Surgical SystemGCJ · Traditional | 01/21/2015SE |
| K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierFZP · Traditional | 12/19/2014SE |
| K141214 | Aquapak Nebulizer Adaptors/ReservoirsCAF · Traditional | 12/18/2014SE |
| K141939 | Telefelx Isis HVT Tracheal Tube, Cuffed with Subglottic Secretion Suction Port; with…BTR · Traditional | 11/24/2014SE |
| K142138 | Iso-Gard MaskCBN · Traditional | 10/30/2014SE |
| K140205 | Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion SystemCAC · Traditional | 10/23/2014SE |
| K140197 | Pleur-Evac Plus Continuous Reinfusion and Autotransfusion SystemCAC · Traditional | 10/21/2014SE |
| K141353 | Hudson Rci Aquapak Humidifier AdaptorBTT · Special | 08/01/2014SE |
| K133439 | Pilling Esophageal BougiesFAT · Traditional | 06/16/2014SE |
| K132415 | Rusch Safety Silk Series Oral/Nasal Tracheal TubeBTR · Traditional | 06/06/2014SE |
| K132946 | Softech Plus ETC02 CannulaCCK · Traditional | 06/04/2014SE |
| K133173 | Rusch Tracflex Plus Pediatric Tracheostomy Tube SetJOH · Traditional | 05/23/2014SE |
| K132729 | Iso-Gard MaskCBN · Special | 01/09/2014SE |
| K132362 | Weck Efx Endo Fascial Closure SystemOCW · Traditional | 10/08/2013SE |
| K122235 | Rusch Tracflex Plus Tracheostomy Tube SetJOH · Special | 09/06/2013SE |
| K123176 | Iso-Gard Clearair MaskCBN · Traditional | 02/14/2013SE |
| K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemCAC · Special | 02/12/2013SE |
| K121796 | Weck Reusable ObturatorGCJ · Traditional | 10/11/2012SE |
| K121380 | Weck Vista Optical Bladeless Laparoscopic Access PortGCJ · Special | 05/25/2012SE |
| K112554 | Transradial Artery Access DevicesDYB · Traditional | 11/18/2011SE |
| K112456 | Adapt(Tm) Universal Balloon Open Access PortGCJ · Special | 10/04/2011SE |
| K111900 | Nextstep Antegrade Chronic Hemodialysis CatheterMSD · Traditional | 08/17/2011SESK |
| K111117 | Cannon II Plus Chronic Hemodialysis Catheter, Edge Chronic Hemodialysis Catheter…MSD · Special | 06/30/2011SESK |
| K102238 | Arrow(R) Nextstep TM Antegrade Chronic Hemodialysis CatheterMSD · Special | 02/01/2011SE |
| K101671 | Single Site Flexible Bladeless ObturatorGCJ · Special | 06/25/2010SE |
| K091761 | Teleflex Isis HVT Tracheal Tube, Cuffed, with Subglottic Secretion Suction PortBTR · Abbreviated | 10/29/2009SE |
| K080230 | Neb-U-Mask System, Models 1895, 1896CAF · Traditional | 06/09/2008SE |
| K070673 | Force Fiber Black Co-Braid Polyethylene Non-Absorbable Surgical SutureGAT · Special | 04/02/2007SE |
| K920908 | Over the Needle Splitable Catheter Assembly Type 1DYB · Traditional | 10/06/1992SE |
| K920907 | Over the Needle Splitable Catheter W/Funnel LocatoDYB · Traditional | 10/06/1992SE |
| K871850 | Teleflex Steerable GuidewireDQX · Traditional | 01/27/1988SE |
| K860258 | Teleflex Teflon Coated GuidewireDQX · Traditional | 05/20/1986SE |
| K852642 | Central Vein Catheterization TrayFDZ · Traditional | 01/16/1986SE |
| K850677 | Teleflex GuidewireDQX · Traditional | 09/17/1985SE |
| K851142 | Telet-Lex Medical IV Catheter PlacementFOZ · Traditional | 07/05/1985SE |
| K851140 | Teleflex Medical Introducer NeedleDWS · Traditional | 06/19/1985SE |
| K851141 | Teleflex Medical Introducer CatheterDYB · Traditional | 05/16/1985SE |