8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAICHEM SPIA C4 REAGENT
FDA 510(k)
FDA Class 2
·Immunology
ARMADA 35/35LL PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PF 5050 PRESSURE UNIT, MODEL PF 5050
FDA 510(k)
FDA Class 2
·Cardiovascular
PATCH
FDA Adverse Event
Injury
·HISTORICAL CPI ST. PAUL·Product code NHW·January 11, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 24, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 3, 2014
ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·January 26, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020