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Sorin Group USA, Inc.

113 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1097-2010)Sorin Group USA, Inc.2010-03-12
Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way recall (Z-1098-2010)Sorin Group USA, Inc.2010-03-12
, REF: 084500500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 I recall (Z-1099-2010)Sorin Group USA, Inc.2010-03-12
Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc recall (Z-0624-2010)Sorin Group USA, Inc.2010-01-14
Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group US recall (Z-0625-2010)Sorin Group USA, Inc.2010-01-14
Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin G recall (Z-0626-2010)Sorin Group USA, Inc.2010-01-14
Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: S recall (Z-0627-2010)Sorin Group USA, Inc.2010-01-14
Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, recall (Z-0628-2010)Sorin Group USA, Inc.2010-01-14
Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sor recall (Z-0629-2010)Sorin Group USA, Inc.2010-01-14
Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R, Manufactured for: Sorin Group recall (Z-0630-2010)Sorin Group USA, Inc.2010-01-14
Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN G recall (Z-0192-2010)Sorin Group USA, Inc.2009-11-13
Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***R recall (Z-0193-2010)Sorin Group USA, Inc.2009-11-13
Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group It recall (Z-2469-2008)Sorin Group USA, Inc.2008-09-30
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Every clearance here is in the API, with alerts when new ones post.