9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SL990, SL980, SL950
FDA 510(k)
FDA Class 2
·Ophthalmic
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141
FDA 510(k)
FDA Class 2
·Orthopedic
MICROETCHER
FDA 510(k)
FDA Class 2
·Dental
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·January 20, 2025
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 9, 2022
FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·February 27, 2013
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·August 8, 2014
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 4, 2011
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 13, 2016