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St Jude Medical CRMD

44 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model N recall (Z-1482-2012)St Jude Medical CRMD2012-05-03
Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex XL Model Nu recall (Z-1483-2012)St Jude Medical CRMD2012-05-03
Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monit recall (Z-0429-2012)St Jude Medical CRMD2012-01-11
Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a p recall (Z-0430-2012)St Jude Medical CRMD2012-01-11
St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582 recall (Z-0457-2012)St Jude Medical CRMD2012-01-11
St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 70 recall (Z-0458-2012)St Jude Medical CRMD2012-01-11
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product recall (Z-2733-2011)St Jude Medical CRMD2011-07-05
Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, recall (Z-1320-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC DR Tiered-Therapy Cardioverter/Defibrillator, recall (Z-1321-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy cardioverter/defibrillator w recall (Z-1322-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC HF Tiered-Therapy Cardioverter/Defibrillator w recall (Z-1323-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy Cardioverter/defibrillator w recall (Z-1324-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy cardioverter/defibrillator recall (Z-1325-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy cardioverter/defibrillator, recall (Z-1326-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator recall (Z-1327-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator recall (Z-1328-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC + HF Tiered-therapy cardioverter/defibrillator recall (Z-1329-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC II VR Tiered-therapy cardioverter/defibrillato recall (Z-1330-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC II DR Tiered-therapy cardioverter/defibrillato recall (Z-1331-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC II+ DR Tiered-therapy cardioverter/defibrillat recall (Z-1332-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC II HF Tiered-therapy cardioverter/defibrillato recall (Z-1333-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy cardioverter/defibrillat recall (Z-1334-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy cardioverter/defibrillat recall (Z-1335-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS + VR Tiered-therapy cardioverter/defibrillato recall (Z-1336-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS DR Tiered-therapy cardioverter/defibrillator, recall (Z-1337-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS + DR Tiered-therapy cardioverter/defibrillato recall (Z-1338-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillato recall (Z-1339-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillato recall (Z-1340-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillato recall (Z-1341-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS II VR Tiered-therapy cardioverter/defibrillat recall (Z-1342-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS II DR Tiered-therapy cardioverter/defibrillat recall (Z-1343-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy cardioverter/defibrilla recall (Z-1344-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS II HF Tiered-therapy cardioverter/defibrillat recall (Z-1345-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy cardioverter/defibrilla recall (Z-1346-2008)St Jude Medical CRMD2008-08-19
Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy cardioverter/defibrilla recall (Z-1347-2008)St Jude Medical CRMD2008-08-19
St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 4 recall (Z-0933-2007)St Jude Medical CRMD2007-06-14
St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia recall (Z-0296-2007)St Jude Medical CRMD2006-12-19
St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycar recall (Z-0297-2007)St Jude Medical CRMD2006-12-19
St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 53 recall (Z-0298-2007)St Jude Medical CRMD2006-12-19
CPS Slitter, Model 410191 recall (Z-1164-06)St Jude Medical CRMD2006-06-24
CPS Valve Bypass Tool (VBT), Model 410192 recall (Z-1165-06)St Jude Medical CRMD2006-06-24
CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 4101 recall (Z-1166-06)St Jude Medical CRMD2006-06-24
CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148 recall (Z-1167-06)St Jude Medical CRMD2006-06-24
CPS Implant Kit, Model 410190 recall (Z-1168-06)St Jude Medical CRMD2006-06-24

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Every clearance here is in the API, with alerts when new ones post.