8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIBIAL PLATEU
FDA 510(k)
FDA Class 2
·Orthopedic
BALL TIP, MODEL #030-185
FDA 510(k)
FDA Class 3
·Cardiovascular
GLASS, NOSEY CUTOUT, BK-1146
FDA 510(k)
FDA Class 1
·Physical Medicine
GENESISXP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 5, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·July 12, 2007
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 3, 2013
STERNAL ZIPFIX WITH NEEDLE STERILE/ 5 PACK
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code JDQ·August 21, 2014
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024