Company ยท US
Medrad, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2014. Name variants (Inc, Corp, punctuation) are merged.
105510(k) clearances (0 in 12 months)
29recalls (0 in 12 months)
26recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXT | Injector And Syringe, Angiographic | 43 |
| MOS | Coil, Magnetic Resonance, Specialty | 18 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 16 |
| FPA | Set, Administration, Intravascular | 10 |
| FRN | Pump, Infusion | 8 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| DQX | Wire, Guide, Catheter | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 |
| LLZ | System, Image Processing, Radiological | 3 |
| MCW | Catheter, Peripheral, Atherectomy | 3 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 3 |
| QEZ | Aspiration Thrombectomy Catheter | 3 |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | 2 |
| FPK | Tubing, Fluid Delivery | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 |
| LHI | Set, I.V. Fluid Transfer | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 |
| EAG | Cephalometer | 1 |
| FOX | Stand, Infusion | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2014 | K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 Medrad, Inc. | MCW |
| Jul 29, 2013 | K130381 | ANGIOJET ULTRA POWER PULSE KIT Medrad, Inc. | QEW |
| Apr 10, 2013 | K130637 | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM Medrad, Inc. | MCW |
| Oct 19, 2012 | K122916 | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM Medrad, Inc. | MCW |
| Jun 6, 2012 | K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET Medrad, Inc. | QEZ |
| Dec 15, 2011 | K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE Medrad, Inc. | DXT |
| Dec 2, 2011 | K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET Medrad, Inc. | QEZ |
| Oct 14, 2011 | K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE Medrad, Inc. | DXT |
| May 24, 2011 | K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET Medrad, Inc. | QEZ |
| Jun 23, 2010 | K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C Medrad, Inc. | FRN |
| Jan 12, 2009 | K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC Medrad, Inc. | DXT |
| Oct 17, 2008 | K082458 | P3T ABDOMEN Medrad, Inc. | JAK |
| Jun 17, 2008 | K080297 | MEDRAD INTEGO PET INFUSION SYSTEM Medrad, Inc. | FRN |
| May 30, 2008 | K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY Medrad, Inc. | FRN |
| Dec 21, 2007 | K072886 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T Medrad, Inc. | DXT |
| Mar 27, 2007 | K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY Medrad, Inc. | IZQ |
| Nov 30, 2006 | K063342 | MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS Medrad, Inc. | MOS |
| May 22, 2006 | K061128 | MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM Medrad, Inc. | FRN |
| Mar 15, 2006 | K060401 | MEDRAD 3.0T ECOIL IMAGING SYSTEM Medrad, Inc. | MOS |
| Nov 17, 2005 | K053042 | MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE Medrad, Inc. | MOS |
| Nov 1, 2005 | K052827 | MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS Medrad, Inc. | MOS |
| Jun 23, 2005 | K051349 | 3.0T PROSTATE IMAGING SYSTEM Medrad, Inc. | MOS |
| Jun 17, 2005 | K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Medrad, Inc. | DXT |
| Jun 7, 2005 | K050371 | MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER Medrad, Inc. | DQO |
| Dec 10, 2004 | K042784 | MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM Medrad, Inc. | DXT |
| Mar 2, 2004 | K033881 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE Medrad, Inc. | DXT |
| Nov 5, 2003 | K033247 | MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM Medrad, Inc. | DXT |
| Sep 23, 2003 | K032771 | MEDRAD CONTINUUM MR INFUSION SYSTEM Medrad, Inc. | FRN |
| Aug 1, 2003 | K031483 | MEDRAD MANUAL SYRINGE LOADER Medrad, Inc. | DXT |
| Jul 11, 2003 | K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET Medrad, Inc. | FPK |
| Jan 10, 2003 | K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc. | DXT |
| Nov 8, 2002 | K023596 | MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL Medrad, Inc. | MOS |
| Sep 5, 2002 | K022431 | MEDRAD TRANSFER SET Medrad, Inc. | FPK |
| Aug 29, 2002 | K021988 | MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM Medrad, Inc. | FRN |
| Dec 13, 2001 | K013815 | MEDRAD QWIK-FIT SYRINGE Medrad, Inc. | DXT |
| Oct 4, 2001 | K012950 | MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM Medrad, Inc. | DXT |
| Aug 21, 2001 | K011991 | MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR Medrad, Inc. | DXT |
| Nov 16, 2000 | K001663 | FRONT-LOAD POLYPROPYLENE SYRINGE Medrad, Inc. | DXT |
| Nov 26, 1999 | K993728 | MEDRAD ENVISION CT INJECTOR SYSTEM Medrad, Inc. | DXT |
| Jul 21, 1999 | K991557 | MEDRAD VISTRON CT INJECTOR SYSTEM Medrad, Inc. | DXT |
| Mar 11, 1999 | K984418 | UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET Medrad, Inc. | DXT |
| Jan 25, 1999 | K984257 | MEDRAD PHASED ARRAY NEUROVASCULAR COIL Medrad, Inc. | MOS |
| Jan 12, 1999 | K984159 | MEDRAD QUADRATURE CTL ARRAY COIL Medrad, Inc. | MOS |
| Nov 3, 1998 | K982959 | MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC Medrad, Inc. | LNH |
| Nov 3, 1998 | K982921 | MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA Medrad, Inc. | MOS |
| Nov 2, 1998 | K982932 | MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC Medrad, Inc. | LNH |
| Nov 2, 1998 | K982919 | MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC Medrad, Inc. | MOS |
| Oct 29, 1998 | K982916 | MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC Medrad, Inc. | MOS |
| Oct 9, 1998 | K982814 | MEDRAD VISTRON CT INJECTOR SYSTEM Medrad, Inc. | DXT |
| Jun 18, 1998 | K981094 | MEDRAD NEUROVASCULAR COIL Medrad, Inc. | MOS |
Newest 50 of 105.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2013 | Medrad Inc DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor:
Product Usage:
Monitor, Physiological, Patient Terminated |
MWI | K042569 |
| Feb 21, 2013 | Medrad Inc MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to Terminated |
DXT | K050456 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Side Step Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary VSA Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infus Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary Spike Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide inf Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary Spike Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infus Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary VSA Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusio Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provid Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion th Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary Administration Kit
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to pr Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Standard Administration Kit
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to pro Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion Pump
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly Terminated |
FRN | K073051 |
| Nov 2, 2011 | Medrad Inc Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865.
Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into Terminated |
DXT | K023183 |
| Jul 22, 2011 | Medrad Inc MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL
Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions Terminated |
DXT | K050456 |
| Nov 15, 2010 | Medrad Inc MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe
The contents of the package are intended to be used in the delivery of contrast me Terminated |
DXT | None listed |
| Jul 9, 2010 | Medrad Inc Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK Terminated |
DXT | K023183 |
| Mar 23, 2010 | Medrad Inc Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231. Terminated |
DXT | K050456 |
| Jun 1, 2009 | Medrad Inc MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media. Terminated |
DXT | None listed |
| Dec 11, 2007 | Medrad Inc Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 150 Terminated |
DXT | None listed |
| Dec 15, 2006 | Medrad Inc Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an accessory to patient physiological monitor. Terminated |
MWI | K042569 |
| Dec 15, 2006 | Medrad Inc Invasive Blood Pressure Interface Cables: a)
Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Bloo Terminated |
MWI | K983250 |
| Nov 16, 2005 | Medrad Inc Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX Terminated |
DXT | K023183 K033881 |
| Oct 25, 2005 | Medrad Inc Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553. Terminated |
JAK | K944983 |
| Oct 21, 2005 | Medrad Inc Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT Terminated |
LHI | K050456 |
| Oct 21, 2005 | Medrad Inc Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT Terminated |
LHI | K050456 |
| May 13, 2005 | Medrad Inc Continuum MR Compatible Infusion Pump. Pump Model #3009135 Terminated |
FRN | K021988 K032771 |
| Nov 24, 2004 | Medrad Inc Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK. Terminated |
DXT | K023183 |
| Oct 22, 2004 | Medrad Inc Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT Terminated |
DXT | K023183 |