8 results
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18ms
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Sources: EU EUDAMED, US FDA
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
FDA 510(k)
FDA Class 1
·Ophthalmic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756394123·PROCEDURE PACK
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
FDA 510(k)
FDA Class 2
·Orthopedic
Medical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 4, 2013
ANNEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 24, 2010
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012