7 results
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34ms
·
Sources: EU EUDAMED, US FDA
SF BROTH
FDA 510(k)
FDA Class 1
·Microbiology
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
FDA 510(k)
FDA Class 2
·Cardiovascular
LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape))
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·November 14, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 13, 2010
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013