Medrad, Inc.
Medrad, Inc. holds FDA 510(k) medical device clearances, first cleared 1976, most recent 2014, with 13 FDA device recalls on record.
Top product codes for Medrad, Inc.
FDA recalls by Medrad, Inc.
10 most recent of 13- Z-1586-2013 — DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
- Z-0870-2013 — 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 cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
- Z-0603-2013 — 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 infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0598-2013 — 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 therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0597-2013 — 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 provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0595-2013 — 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 prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0600-2013 — 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 infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0599-2013 — 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 provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0601-2013 — 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 infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0605-2013 — 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 therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medrad, Inc.
1–100 of 105- K133023 — JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
- K130381 — ANGIOJET ULTRA POWER PULSE KIT
- 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
- K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
- K113363 — ANGIOJET SOLENT DISTA THROMBECTOMY SET
- K113133 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE
- K113428 — ANGIOJET ULTRA DVX THROMBECTOMY SET
- K112086 — MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE
- K111182 — ANGIOJET SOLENT OMNI THROMBECTOMY SET
- K100798 — MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C
- K082905 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
- K082458 — P3T ABDOMEN
- K080297 — MEDRAD INTEGO PET INFUSION SYSTEM
- K073051 — MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
- K072886 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T
- K063090 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
- K063342 — MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
- K061128 — MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
- K060401 — MEDRAD 3.0T ECOIL IMAGING SYSTEM
- K053042 — MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
- K052827 — MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
- K051349 — 3.0T PROSTATE IMAGING SYSTEM
- K050456 — MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM
- K050371 — MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
- K042784 — MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
- K033881 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
- K033247 — MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
- K032771 — MEDRAD CONTINUUM MR INFUSION SYSTEM
- K031483 — MEDRAD MANUAL SYRINGE LOADER
- K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET
- K023183 — MEDRAD STELLANT CT INJECTOR SYSTEM
- K023596 — MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
- K022431 — MEDRAD TRANSFER SET
- K021988 — MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
- K013815 — MEDRAD QWIK-FIT SYRINGE
- K012950 — MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
- K011991 — MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
- K001663 — FRONT-LOAD POLYPROPYLENE SYRINGE
- K993728 — MEDRAD ENVISION CT INJECTOR SYSTEM
- K991557 — MEDRAD VISTRON CT INJECTOR SYSTEM
- K984418 — UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
- K984257 — MEDRAD PHASED ARRAY NEUROVASCULAR COIL
- K984159 — MEDRAD QUADRATURE CTL ARRAY COIL
- K982921 — MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
- K982959 — MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
- K982919 — MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
- K982932 — MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
- K982916 — MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
- K982814 — MEDRAD VISTRON CT INJECTOR SYSTEM
- K981094 — MEDRAD NEUROVASCULAR COIL
- K980417 — MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V
- K974438 — MEDRAD ATD-T INTERFACE DEVICE
- K974308 — MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY
- K973787 — MEDRAD 1.5T EXTREMITY ARRAY
- K971380 — MEDRAD FLEX INTERFACE DEVICE
- K964642 — MEDRAD DISPOSABLE SYRINGES
- K964782 — MEDRAD CONTRAST HOLDER
- K964854 — MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
- K960901 — MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
- K954952 — MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL
- K955626 — MEDRAD/HITACHI BREAST IMAGING SURFACE COIL
- K935668 — MEDRAD SPECTRIS MR INJECTOR
- K943189 — MEDRAD QWIK-FIX MRI DISPOSABLE KIT
- K952232 — MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15
- K952235 — MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15
- K934086 — MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
- K944983 — MEDRAD COUNTERPOISE SYSTEM
- K933908 — MEDRAD CT CUSTOM CONVENIENCE KIT
- K932403 — AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN
- K930779 — MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
- K930544 — MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15
- K932292 — AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS
- K926571 — MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15
- K925029 — MRINNERVU ENDORECTAL PROSTATE COIL
- K924116 — MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
- K922274 — MEDRAD PATHFINDER-E ROADMAPPING SYSTEM
- K913624 — MEDRAD MCT-PLUS INJECTOR
- K914366 — MEDRAD PATHFINDER HR ROADMAPPING SYSTEM
- K905819 — MEDRAD VARIBLE INFUSION INJECTOR
- K903390 — MEDRAD MARK V-PLUS INJECTOR
- K901888 — PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15
- K900586 — MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE
- K890394 — MEDRAD SCPD 1000
- K884317 — MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
- K883604 — MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
- K883834 — MEDRAD OMNIPLANE 300 SYSTEM
- K880332 — MEDRAD OPEN ENDED GUIDEWIRE
- K880493 — MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
- K874451 — OMNIPLANE 200 FILM CHANGER SYSTEM
- K873173 — MEDRAD MRI INJECTION SYSTEM
- K874928 — WHOLEY (TM) BIOPSY DEVICE
- K870243 — BURNETT TMJ APPLIANCE
- K840281 — ANGIOGRAPHIC DRAPE PACKS
- K831188 — CONNECTOR TUBE
- K831189 — ANGIOGRAPHIC NEEDLE
- K831190 — VESSEL DILATOR
- K831191 — VASCULAR CATHETER
- K822536 — MARK V
- K810924 — MEDRAD HIGH PRESSURE CONECTING TUBE
- K802473 — BENZALKONIUM-HEPARIN COATED GUIDEWIRES
Data sourced from openFDA. This site is unofficial and independent of the FDA.