BEUDAMED
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    EMIT C-REACTIVE PROTEIN AUTOCAROUSEL

    FDA 510(k)
    FDA Class 2 ·Immunology

    CONVOY ADVANCED DELIVERY SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    TYPE 1077 ACCUSCREEN

    FDA 510(k)
    FDA Class 2 ·Neurology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 9, 2012

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·August 22, 2010

    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