BEUDAMED
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    ABBOTT SPECTRUM AMMONIA REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Powered Wheelchair DYW30A(D09)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LATITUDE ELBOW PROTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA Adverse Event
    Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code HRX·June 12, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·December 12, 2012

    QUATTRODE 3/4 LEAD, 60CM LENGTH

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·September 29, 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