Greatbatch Medical

13 FDA 510(k) clearances · Recalling firm

Record	Firm	Date
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100 recall (Z-0367-2017)	Greatbatch Medical	2016-11-29
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micr recall (Z-0623-2017)	Greatbatch Medical	2016-11-18
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part recall (Z-1614-2014)	Greatbatch Medical	2014-05-13
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T104 recall (Z-1119-2014)	Greatbatch Medical	2014-03-06
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manuf recall (Z-1608-2013)	Greatbatch Medical	2013-06-27
45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model # recall (Z-0751-2013)	Greatbatch Medical	2013-01-30
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, recall (Z-0611-2013)	Greatbatch Medical	2012-12-22
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, recall (Z-0132-2013)	Greatbatch Medical	2012-10-24
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Bosto recall (Z-2459-2012)	Greatbatch Medical	2012-09-26
enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Co recall (Z-0287-2011)	Greatbatch Medical	2010-11-02
Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 10000 recall (Z-2294-2010)	Greatbatch Medical	2010-08-27
Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized b recall (Z-0580-2010)	Greatbatch Medical	2009-12-29
Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner p recall (Z-0581-2010)	Greatbatch Medical	2009-12-29

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