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ela Medical Llc

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sori recall (Z-2609-2011)ela Medical Llc2011-06-22
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Ital recall (Z-2579-2010)ela Medical Llc2010-09-27
Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMe recall (Z-2235-2009)ela Medical Llc2009-09-24
Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pace recall (Z-0266-06)ela Medical Llc2005-12-02
ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minu recall (Z-0267-06)ela Medical Llc2005-12-02
Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Vent recall (Z-1587-05)ela Medical Llc2005-09-24
Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventr recall (Z-1597-05)ela Medical Llc2005-09-24
Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ve recall (Z-1598-05)ela Medical Llc2005-09-24
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, t recall (Z-0801-05)ela Medical Llc2005-05-06
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, t recall (Z-0802-05)ela Medical Llc2005-05-06
Alto implantable cardioverter defibrillator recall (Z-0176-05)ela Medical Llc2004-11-04

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Every clearance here is in the API, with alerts when new ones post.