7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FlexCath Cross Transseptal Solution
FDA 510(k)
FDA Class 2
·Cardiovascular
SAFYRE VS AND SAFYRE T
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXTRIMILOCK ANKLE PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
LARGE MOD HEAD ADAPT 12/14 +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 6, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025