11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AETOS Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
LANEX Fine Screens
FDA UDI
CARESTREAM HEALTH, INC.·60889971220844·PR 24 X 30CM LANEX FINE SCREEN C-2
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ET/SS IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code LWR·October 28, 2008
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·August 23, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 11, 2013
ATTUNE CR FB INSRT SZ 6 5MM
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code JWH·October 14, 2024
ATTUNE CR FB INSRT SZ 6 5MM
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code JWH·October 14, 2024
ATTUNE CR FB INSRT SZ 6 5MM
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code JWH·October 14, 2024
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 28, 2014