BEUDAMED
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    SERATEST ENA [SS-B] KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    URICAR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·October 8, 2010

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·October 3, 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