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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 11 Results
PMA Number: P980049
 
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PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF ... 2 May-18-2017 Sorin Group Italia SRL - CRF
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARA... 2 May-18-2017 Sorin Group Italia SRL - CRF
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARAD... 2 May-18-2017 Sorin Group Italia SRL - CRF
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program ... 2 Nov-15-2016 Sorin Group USA, Inc.
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and i... 2 Nov-15-2016 Sorin Group USA, Inc.
ORCHESTRA/ORCHESTRA PLUS Programmer 2 Jan-22-2014 Sorin Group Italia S.r.l.
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are... 2 Mar-08-2013 Sorin Group USA, Inc.
Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. ... 2 Jun-22-2011 ela Medical Llc
Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular an... 2 Sep-24-2005 ela Medical Llc
Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular a... 2 Sep-24-2005 ela Medical Llc
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