Company ยท US
St Jude Medical CRMD
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2010. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
44recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQY | Catheter, Percutaneous | 5 |
| DXY | Implantable Pacemaker Pulse-Generator | 3 |
| KRG | Programmer, Pacemaker | 2 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 2 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 2 |
| DTA | Tester, Pacemaker Electrode Function | 1 |
| MCX | Catheter, Coronary, Atherectomy | 1 |
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2012 | St Jude Medical CRMD Cardiac Resynchronization Therapy (CRT) Leads
Trade Name: QuickFlex, QuickFlex XL
Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T
Intended use: Left Ventricular Cardiac Res Terminated |
NIK | None listed |
| May 3, 2012 | St Jude Medical CRMD Cardiac Resynchronization Therapy (CRT) Leads.
Trade Name: QuickSite, QuickSite XL
Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T
Intended use: Left Ventricular Cardiac Re Terminated |
NIK | None listed |
| Jan 11, 2012 | St Jude Medical CRMD St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
Product Usage: These Silicone transvenous high voltage (HV) le Terminated |
LWS | None listed |
| Jan 11, 2012 | St Jude Medical CRMD St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable Terminated |
LWS | None listed |
| Jan 11, 2012 | St Jude Medical CRMD Anthem CRT-P models PM3110 and PM3210
St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. Terminated |
DXY | None listed |
| Jan 11, 2012 | St Jude Medical CRMD Implantable Pacemaker Accent DR models PM2110 and PM2210
St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. Terminated |
DXY | None listed |
| Jul 5, 2011 | St Jude Medical CRMD SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE).
This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing i Terminated |
MXC | K081365 |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS II+ HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-367 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS II+ HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-366 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS II HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-365 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS II+ DR Tiered-therapy cardioverter/defibrillator, Model V-268 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS II DR Tiered-therapy cardioverter/defibrillator, Model V-265 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS II VR Tiered-therapy cardioverter/defibrillator, Model V-168 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS + HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-343 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS + HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-340 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS + HF Tiered-therapy cardioverter/defibrillator with biventricular strimulation, Model V-341 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS + DR Tiered-therapy cardioverter/defibrillator, Model V-243 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS DR Tiered-therapy cardioverter/defibrillator, Model V-242 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
ATLAS + VR Tiered-therapy cardioverter/defibrillator, Model V-193 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC II+ HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-356 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC II+ HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-357 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC II HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-355 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC II+ DR Tiered-therapy cardioverter/defibrillator, Model V-258 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC II DR Tiered-therapy cardioverter/defibrillator, Model V-255 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC II VR Tiered-therapy cardioverter/defibrillator, Model V-158 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC + HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-350 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-239 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-236 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC DR Tiered-therapy cardioverter/defibrillator, Model V-233 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC + VR Tiered-therapy cardioverter/defibrillator, Model V-196 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-339 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC HF Tiered-Therapy Cardioverter/Defibrillator with Biventricular Stimulation, Model V-338 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-337 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC DR Tiered-Therapy Cardioverter/Defibrillator, Model V-235 Terminated |
None listed | |
| Aug 19, 2008 | St Jude Medical CRMD Implantable Cardioverter Defibrillator
EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197 Terminated |
None listed | |
| Jun 14, 2007 | St Jude Medical CRMD St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126. Terminated |
MCX | K053277 |
| Dec 19, 2006 | St Jude Medical CRMD St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers) Terminated |
DXY | None listed |
| Dec 19, 2006 | St Jude Medical CRMD St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650 Terminated |
KRG | None listed |
| Dec 19, 2006 | St Jude Medical CRMD St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510 Terminated |
KRG | None listed |
| Jun 24, 2006 | St Jude Medical CRMD CPS Implant Kit, Model 410190 Terminated |
DQY | K053217 |
| Jun 24, 2006 | St Jude Medical CRMD CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148 Terminated |
DQY | K053217 |
| Jun 24, 2006 | St Jude Medical CRMD CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126 Terminated |
DQY | K053217 |
| Jun 24, 2006 | St Jude Medical CRMD CPS Valve Bypass Tool (VBT), Model 410192 Terminated |
DQY | K053217 |
| Jun 24, 2006 | St Jude Medical CRMD CPS Slitter, Model 410191 Terminated |
DQY | K053217 |