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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 15 Results
PMA Number: P980049
 
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Alto implantable cardioverter defibrillator 2 11/04/2004 ela Medical Llc
Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular a... 2 09/24/2005 ela Medical Llc
Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular an... 2 09/24/2005 ela Medical Llc
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARAD... 2 05/18/2017 Sorin Group Italia SRL - CRF
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are... 2 03/08/2013 Sorin Group USA, Inc.
ORCHESTRA/ORCHESTRA PLUS Programmer 2 01/22/2014 Sorin Group Italia S.r.l.
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARA... 2 05/18/2017 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 ... 2 05/18/2017 Sorin Group Italia SRL - CRF
Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. ... 2 06/22/2011 ela Medical Llc
Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrill... 2 09/28/2017 Sorin Group Italia SRL - CRF
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