Medrad Inc
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 105
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1586-2013 | Class II | DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product U | April 15, 2013 |
| Z-0870-2013 | Class II | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization proce | November 5, 2012 |
| Z-0598-2013 | Class II | Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients | April 18, 2012 |
| Z-0600-2013 | Class II | Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patie | April 18, 2012 |
| Z-0602-2013 | Class II | Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patient | April 18, 2012 |
| Z-0603-2013 | Class II | Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for p | April 18, 2012 |
| Z-0599-2013 | Class II | Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed | April 18, 2012 |
| Z-0595-2013 | Class II | Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require me | April 18, 2012 |
| Z-0601-2013 | Class II | Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for pat | April 18, 2012 |
| Z-0605-2013 | Class II | Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patient | April 18, 2012 |
| Z-0596-2013 | Class II | Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System design | April 18, 2012 |
| Z-0604-2013 | Class II | Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for pat | April 18, 2012 |
| Z-0597-2013 | Class II | Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System desig | April 18, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | August 27, 2014 |
| K130381 | ANGIOJET ULTRA POWER PULSE KIT | July 29, 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 | April 10, 2013 |
| K122916 | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM | October 19, 2012 |
| K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | June 6, 2012 |
| K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRI | December 15, 2011 |
| K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET | December 2, 2011 |
| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | October 14, 2011 |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | May 24, 2011 |
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS | June 23, 2010 |
| K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC | January 12, 2009 |
| K082458 | P3T ABDOMEN | October 17, 2008 |
| K080297 | MEDRAD INTEGO PET INFUSION SYSTEM | June 17, 2008 |
| K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY | May 30, 2008 |
| K072886 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T | December 21, 2007 |
| K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | March 27, 2007 |
| K063342 | MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS | November 30, 2006 |
| K061128 | MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM | May 22, 2006 |
| K060401 | MEDRAD 3.0T ECOIL IMAGING SYSTEM | March 15, 2006 |
| K053042 | MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE | November 17, 2005 |