7 results
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17ms
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Sources: EU EUDAMED, US FDA
H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H9014
FDA 510(k)
FDA Class 1
·Hematology
Navina Classic System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·June 12, 2014
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·October 6, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 12, 2012
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