Medrad, Inc.
Medical device manufacturer in Minneapolis, MN.
105510(k) clearances
0PMA approvals
22recalls
Device types
- DXT Injector And Syringe, Angiographic 32
- MOS Coil, Magnetic Resonance, Specialty 18
- LNH System, Nuclear Magnetic Resonance Imaging 16
- FRN Pump, Infusion 6
- DQO Catheter, Intravascular, Diagnostic 3
- QEZ Aspiration Thrombectomy Catheter 3
- MCW Catheter, Peripheral, Atherectomy 3
- LLZ System, Image Processing, Radiological 3
- DQX Wire, Guide, Catheter 3
- JAA System, X-Ray, Fluoroscopic… 2
- JAK System, X-Ray, Tomography, Computed 2
- DOY Radioimmunoassay, Digoxin (3-H), Goat… 2
- FPK Tubing, Fluid Delivery 2
- GDM Needle, Aspiration And Injection, Reusable 1
- IZP Programmer, Changer, Film/Cassette… 1
- KPR System, X-Ray, Stationary 1
- EAG Cephalometer 1
- DRE Dilator, Vessel, For Percutaneous… 1
- QEW Peripheral Mechanical Thrombectomy With… 1
- DWE Tubing, Pump, Cardiopulmonary Bypass 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K133023 | Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6MCW · Traditional | 08/27/2014SE |
| K130381 | Angiojet Ultra Power Pulse KitQEW · Traditional | 07/29/2013SE |
| K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…MCW · Special | 04/10/2013SE |
| K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…MCW · Special | 10/19/2012SE |
| K113363 | Angiojet Solent Dista Thrombectomy SetQEZ · Traditional | 06/06/2012SE |
| K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 12/15/2011SE |
| K113428 | Angiojet Ultra DVX Thrombectomy SetQEZ · Special | 12/02/2011SE |
| K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 10/14/2011SE |
| K111182 | Angiojet Solent Omni Thrombectomy SetQEZ · Special | 05/24/2011SE |
| K100798 | Medrad Intego PET Infusion System, Source Administration Set, Patient Adminstratin Set…FRN · Traditional | 06/23/2010SE |
| K082905 | Medrad Stellant CT Injector System with P3T CardiacDXT · Traditional | 01/12/2009SE |
| K082458 | P3T AbdomenJAK · Traditional | 10/17/2008SE |
| K080297 | Medrad Intego PET Infusion SystemFRN · Traditional | 06/17/2008SE |
| K073051 | Medrad Continuum MR Infusion System with Wireless Remote AccessoryFRN · Abbreviated | 05/30/2008SE |
| K072886 | Medrad Stellant CT Injector System with P3TDXT · Traditional | 12/21/2007SE |
| K063090 | Medrad Stellant CT Injector System with XDS AccessoryIZQ · Traditional | 03/27/2007SE |
| K063342 | Medrad Ecoil Imaging System for PhilipsMOS · Special | 11/30/2006SE |
| K061128 | Modification to Medrad Continuum MR Infusion SystemFRN · Special | 05/22/2006SE |
| K060401 | Medrad 3.0T Ecoil Imaging SystemMOS · Special | 03/15/2006SE |
| K053042 | Medrad 1.5T Pelvic Imaging System Interface DeviceMOS · Special | 11/17/2005SE |
| K052827 | Modification to Medrad 8-RECEIVER Phased Array Neurovascular Coil for SiemensMOS · Special | 11/01/2005SE |
| K051349 | 3.0T Prostate Imaging SystemMOS · Special | 06/23/2005SE |
| K050456 | Medrad Avanta Fluid Management Injection SystemDXT · Traditional | 06/17/2005SE |
| K050371 | Medrad Vanguard DX Angiographic CatheterDQO · Traditional | 06/07/2005SE |
| K042784 | Medrad Spectris Solaris Ep MR Injector SystemDXT · Special | 12/10/2004SE |
| K033881 | Medrad Stellant CT Injector System with Imaging System Interface ModuleDXT · Special | 03/02/2004SE |
| K033247 | Medrad Spectris Solaris MR Injector SystemDXT · Special | 11/05/2003SE |
| K032771 | Medrad Continuum MR Infusion SystemFRN · Special | 09/23/2003SE |
| K031483 | Medrad Manual Syringe LoaderDXT · Traditional | 08/01/2003SE |
| K031808 | Medrad Swabbable Valve Transfer SetFPK · Special | 07/11/2003SE |
| K023183 | Medrad Stellant CT Injector SystemDXT · Special | 01/10/2003SE |
| K023596 | Medrad 8-RECEIVER Phased Array Neurovascular CoilMOS · Special | 11/08/2002SE |
| K022431 | Medrad Transfer SetFPK · Traditional | 09/05/2002SE |
| K021988 | Medrad Continuum MR Compatible Infusion SystemFRN · Abbreviated | 08/29/2002SE |
| K013815 | Medrad Qwik-Fit SyringeDXT · Special | 12/13/2001SE |
| K012950 | Modification to: Medrad Spectris Solaris MR Injector SystemDXT · Special | 10/04/2001SE |
| K011991 | Modification to Medrad Spectris MR InjectorDXT · Special | 08/21/2001SE |
| K001663 | Front-Load Polypropylene SyringeDXT · Traditional | 11/16/2000SE |
| K993728 | Medrad Envision CT Injector SystemDXT · Special | 11/26/1999SE |
| K991557 | Medrad Vistron CT Injector SystemDXT · Special | 07/21/1999SE |
| K984418 | Universal Adjustable T-Rail Table BracketDXT · Traditional | 03/11/1999SE |
| K984257 | Medrad Phased Array Neurovascular CoilMOS · Traditional | 01/25/1999SE |
| K984159 | Medrad Quadrature CTL Array CoilMOS · Traditional | 01/12/1999SE |
| K982959 | Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSCLNH · Traditional | 11/03/1998SE |
| K982921 | Medrad 0.5T, 1.0T & 1.5T Breast Coil, Models M21BRC, M42BRA, M64BRAMOS · Traditional | 11/03/1998SE |
| K982932 | Medrad Anterior Neck Coil, 1.5T & 1.0T Model Numbers M64ANC and M42ANCLNH · Traditional | 11/02/1998SE |
| K982919 | Medrad Quad T/L Coil (1.5T, 1.0T & 0.5T) Models M64TLC, M42TLC, M21TLCMOS · Traditional | 11/02/1998SE |
| K982916 | Medrad 1.5T, 1.0T & 0.5T Shoulder Coil, Models M64SHC, M42SHC, M21SHCMOS · Traditional | 10/29/1998SE |
| K982814 | Medrad Vistron CT Injector SystemDXT · Special | 10/09/1998SE |
| K981094 | Medrad Neurovascular CoilMOS · Traditional | 06/18/1998SE |
| K980417 | Medrad Disposable MRI Kit W/Check Valve Modelsqk 65V, Medrad MRI Integral T with Check…LNH · Traditional | 05/04/1998SE |
| K974438 | Medrad Atd-T Interface DeviceMOS · Traditional | 04/30/1998SE |
| K974308 | Medrad 1.5T Peripheral Vascular ArrayMOS · Traditional | 01/27/1998SE |
| K973787 | Medrad 1.5T Extremity ArrayMOS · Traditional | 12/30/1997SE |
| K971380 | Medrad Flex Interface DeviceLNH · Traditional | 07/03/1997SE |
| K964642 | Medrad Disposable SyringesDXT · Traditional | 04/29/1997SE |
| K964782 | Medrad Contrast HolderFOX · Traditional | 02/25/1997SE |
| K964854 | Medrad Phased Array 1.5T Shoulder Imaging Surgace CoilMOS · Traditional | 02/11/1997SE |
| K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface CoilLNH · Traditional | 05/29/1996SE |
| K954952 | Medrad/Hitachi 1.5T Quad C-Spine Surface CoilMOS · Traditional | 03/13/1996SE |
| K955626 | Medrad/Hitachi Breast Imaging Surface CoilMOS · Traditional | 02/27/1996SE |
| K935668 | Medrad Spectris MR InjectorDXT · Traditional | 09/25/1995SE |
| K943189 | Medrad Qwik-Fix MRI Disposable KitLNH · Traditional | 08/09/1995SE |
| K952235 | Mriinnervu Disposable Endorectal Cervic Coil, Catalog No. BCR-15LNH · Traditional | 06/26/1995SE |
| K952232 | Mrinnervu Disposable Endorectal Colon Coil, Catalong No. PCC-15LNH · Traditional | 06/26/1995SE |
| K934086 | Medrad Envision CT Injector and Qwik Fit SyringeDXT · Traditional | 06/15/1995SE |
| K944983 | Medrad Counterpoise SystemJAK · Traditional | 11/29/1994SE |
| K933908 | Medrad CT Custom Convenience KitDXT · Traditional | 02/25/1994SE |
| K932403 | Autotune Device (Atd Ii)/Philips S-15/ACS MRI ScanLNH · Traditional | 02/24/1994SE |
| K930779 | Mrinnervu Disposable Endorectal Cervix COIL#BCR-15LNH · Traditional | 10/07/1993SE |
| K930544 | Mrinnervu Disposable Endorectal Colon COIL,#PCC-15LNH · Traditional | 09/29/1993SE |
| K932292 | Autotune Device (Atd II) for Picker MRI SystemsLNH · Traditional | 08/26/1993SE |
| K926571 | Mrinnervu(R) Endorectal Prostate Coil BPX-15LNH · Traditional | 07/20/1993SE |
| K925029 | Mrinnervu Endorectal Prostate CoilLNH · Traditional | 05/19/1993SE |
| K924116 | Medrad MCT, MCT Plus Injector/Medrad Front LoadDXT · Traditional | 01/21/1993SE |
| K922274 | Medrad Pathfinder-E Roadmapping SystemJAA · Traditional | 10/09/1992SE |
| K913624 | Medrad Mct-Plus InjectorDXT · Traditional | 07/30/1992SE |
| K914366 | Medrad Pathfinder HR Roadmapping SystemLLZ · Traditional | 02/27/1992SE |
| K905819 | Medrad Varible Infusion InjectorDXT · Traditional | 09/16/1991SE |
| K903390 | Medrad Mark V-Plus InjectorDXT · Traditional | 09/26/1990SE |
| K901888 | Prostate Probe Surface Coil, Catalog #BPX-15LNH · Traditional | 08/10/1990SE |
| K900586 | Medrad Fluorovision HR 2000, High Resolution ImageLLZ · Traditional | 02/23/1990SE |
| K890394 | Medrad SCPD 1000LNH · Traditional | 03/14/1989SE |
| K884317 | Medrad Fluoroscopic Video Enhancement SystemJAA · Traditional | 12/20/1988SE |
| K883604 | Medrad Image Management System (Mims)LLZ · Traditional | 11/15/1988SE |
| K883834 | Medrad Omniplane 300 SystemKPR · Traditional | 11/04/1988SE |
| K880332 | Medrad Open Ended GuidewireDQX · Traditional | 07/28/1988SE |
| K880493 | Medrad Microprocessor CT Injection SystemDXT · Traditional | 04/28/1988SE |
| K874451 | Omniplane 200 Film Changer SystemIZP · Traditional | 02/11/1988SE |
| K873173 | Medrad MRI Injection SystemDXT · Traditional | 02/05/1988SE |
| K874928 | Wholey (TM) Biopsy DeviceGDM · Traditional | 12/30/1987SE |
| K870243 | Burnett TMJ ApplianceEAG · Traditional | 02/24/1987SE |
| K840281 | Angiographic Drape PacksDXT · Traditional | 04/17/1984SE |
| K831191 | Vascular CatheterDOY · Traditional | 05/09/1983SE |
| K831190 | Vessel DilatorDRE · Traditional | 05/09/1983SE |
| K831189 | Angiographic NeedleDQO · Traditional | 05/09/1983SE |
| K831188 | Connector TubeDOY · Traditional | 05/09/1983SE |
| K822536 | Mark VDXT · Traditional | 09/28/1982SE |
| K810924 | Medrad High Pressure Conecting TubeDWE · Traditional | 04/17/1981SE |
| K802473 | Benzalkonium-Heparin Coated GuidewiresDQX · Traditional | 11/12/1980SE |
| K800823 | Quick FillDXT · Traditional | 04/29/1980SE |
| K800613 | Angioplasty InjectorDXT · Traditional | 04/08/1980SE |
| K791959 | Post Extra Systolic PostentlatorIXO · Traditional | 01/09/1980SE |
| K781819 | Post Extra Systolic PotentiatorDQO · Traditional | 01/15/1979SE |
| K760944 | Angiographic GuidewireDQX · Traditional | 12/10/1976SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1586-2013 Class II | DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor:…The firm is recalling these power cables due to a latent design reliability issue and the potential for… | 04/15/2013Terminated |
| Z-0870-2013 Class II | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac…The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath… | 11/05/2012Terminated |
| Z-0605-2013 Class II | Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0604-2013 Class II | Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0603-2013 Class II | Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0602-2013 Class II | Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0601-2013 Class II | Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0600-2013 Class II | Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0599-2013 Class II | Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0598-2013 Class II | Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0597-2013 Class II | Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0596-2013 Class II | Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0595-2013 Class II | Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who…Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and… | 04/18/2012Terminated |
| Z-0147-2012 | Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865.…Packaging may exhibit open seals - sterility compromised | 10/24/2011Terminated |
| Z-2866-2011 | MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500…Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection… | 06/02/2011Terminated |
| Z-1954-2010 | Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPKKits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause… | 05/24/2010Terminated |
| Z-0367-2011 | MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes…Some kits have a hole in the packaging which could compromise the sterility of the components. | 05/17/2010Terminated |
| Z-1199-2010 | Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT)…The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging. | 01/06/2010Terminated |
| Z-1228-2009 | MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe…Possible compromised sterility due to holes in styrene tray | 01/29/2009Terminated |
| Z-0292-2008 | Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and…Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised | 10/25/2007Terminated |
| Z-0259-2007 | Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an…Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible… | 09/29/2006Terminated |
| Z-0258-2007 | Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI…Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible… | 09/29/2006Terminated |