7 results
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27ms
·
Sources: EU EUDAMED, US FDA
CARDIOTOMY RESERVOIR-FILTER 050-108-050
FDA 510(k)
FDA Class 2
·Cardiovascular
STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
FDA 510(k)
FDA Unclassified
·Unknown
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
ANEURX STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·November 14, 2012
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 13, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024