BEUDAMED
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    PRISMA DISPOSABLE J-SHAPED I/A CANNULA

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TOXOPLASMA GONDII

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OPTETRAK FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KXA·June 9, 2014

    EZ-PRO R4 AMBUL COT OBS(5/08)

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIV.·Product code FPO·October 13, 2010

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 17, 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