Product code MRM ยท Class 3
Defibrillator, Implantable, Dual-Chamber
0510(k)s in 12 months (0 all time)
0recalls in 12 months (34 all time)
0recalls that name a 510(k)
Top companies in MRM
| Company | 510(k)s | Recalls |
|---|---|---|
| BIOTRONIK Inc | 0 | 22 |
| Sorin Group Italia SRL - CRF | 0 | 7 |
| ela Medical Llc | 0 | 4 |
| Sorin Group USA, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life- Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment o Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of lif Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-t Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of li Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life- Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-th Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threate Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-th Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of lif Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-th Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threa Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threat Terminated |
MRM | None listed |
| Mar 8, 2021 | BIOTRONIK Inc BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threat Terminated |
MRM | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia Terminated |
MRM | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia Terminated |
MRM | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia det Terminated |
MRM | None listed |
| Sep 28, 2017 | Sorin Group Italia SRL - CRF Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator,
Biventricular or ventricular antitachycardia pacing,
Dual or single chamber arrhythmia det Terminated |
MRM | None listed |
| Apr 11, 2017 | Sorin Group Italia SRL - CRF INTENSIA Models: VR 124, DR 154, CRT-D 174
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 15 Terminated |
MRM | None listed |
| Apr 11, 2017 | Sorin Group Italia SRL - CRF PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM Terminated |
MRM | None listed |
| Apr 11, 2017 | Sorin Group Italia SRL - CRF OVATIO Models: VR 6250, DR 6550, CRT 6750.
Product Usage:
OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 1 Terminated |
MRM | None listed |
| Mar 8, 2013 | Sorin Group USA, Inc. Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6.
These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatme Terminated |
MRM | None listed |
| Jun 22, 2011 | ela Medical Llc Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy
PARADYM DR 8550 and PARADYM VR 8250 are indicat Terminated |
MRM | None listed |
| Jul 29, 2008 | Biotronik Inc Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; I Terminated |
MRM | None listed |
| Sep 24, 2005 | ela Medical Llc Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, Terminated |
MRM | None listed |
| Sep 24, 2005 | ela Medical Llc Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, Terminated |
MRM | None listed |
| Sep 24, 2005 | ela Medical Llc Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, r Terminated |
MRM | None listed |
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