ClearanceBrief
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)
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Top companies in MRM

DateFirm and productCodeLinked 510(k)
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Mar 8, 2021BIOTRONIK 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
MRMNone listed
Sep 28, 2017Sorin 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
MRMNone listed
Sep 28, 2017Sorin 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
MRMNone listed
Sep 28, 2017Sorin 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
MRMNone listed
Sep 28, 2017Sorin 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
MRMNone listed
Apr 11, 2017Sorin 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
MRMNone listed
Apr 11, 2017Sorin 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
MRMNone listed
Apr 11, 2017Sorin 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
MRMNone listed
Mar 8, 2013Sorin 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
MRMNone listed
Jun 22, 2011ela 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
MRMNone listed
Jul 29, 2008Biotronik 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
MRMNone listed
Sep 24, 2005ela 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
MRMNone listed
Sep 24, 2005ela 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
MRMNone listed
Sep 24, 2005ela 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
MRMNone listed

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