Company
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
198recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 80 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 73 |
| NVZ | Pulse Generator, Permanent, Implantable | 16 |
| OSR | Pacemaker/Icd/Crt Non-Implanted Components | 12 |
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | 5 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 3 |
| DQY | Catheter, Percutaneous | 2 |
| PNJ | Leadless Pacemaker | 2 |
| DTE | Pulse-Generator, Pacemaker, External | 1 |
| NVY | Permanent Defibrillator Electrodes | 1 |
| NWD | 1 | |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 1 |
| QAN | Stent, Iliac Vein | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators Open, Classified |
NIK | None listed |
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