8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TiLink-L SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Sbo Hearing A/S·05714464029655·OTICON F500 MINIRITE T C090
REPICCI LOCKED KEEL TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
FASTBRACES CERAMIC BRACKETS
FDA 510(k)
FDA Class 2
·Dental
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·November 7, 2008
LRESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·August 15, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025