BEUDAMED
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    MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CREATININE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050

    FDA 510(k)
    FDA Class 2 ·Dental

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·May 23, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 10, 2012

    ROCKERSWITCH PENCIL

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·June 23, 2015

    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