15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Transpara
FDA 510(k)
FDA Class 2
·Radiology
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZIMMER DTO PIN PRESS INSTRUMENT
FDA 510(k)
FDA Class 2
·Orthopedic
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 21, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 27, 2011
PGW .018 SV SHORT
FDA Adverse Event
Malfunction
·CORDIS CORPORATION·Product code DQX·September 30, 2008
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 14, 2025
UNKNOWN JOINT REPAIR DEVICE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026
UNKN JOINT REPAIR DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026
UNKNOWN
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026
UNKNOWN JOINT REPAIR DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026
UNKNOWN JOINT REPAIR DEVICE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026
UNKN JOINT REPAIR DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026
UNKN JOINT REPAIR DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020