9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CONSENSUS 22MM COCRMO FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
MEDTRONIC NAVIGATION, INC.·00673978088846·INST 960-339 EGG QUICK CONNECT HANDLE
Cardinal Health Isolation Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
FDA 510(k)
FDA Class 2
·General Hospital
INST 960-339 EGG QUICK CONNECT HANDLE
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·September 13, 2016
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·February 8, 2013
2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·December 16, 2010
NATURA 2 PC - STOMAHESIVE WAFER W/FLEX COLLAR
FDA Adverse Event
Injury
·CONVATEC INC·Product code EXE·July 17, 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