BEUDAMED
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    AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    SOMATOM SPIRIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    nvc

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·June 1, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 9, 2012

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·August 30, 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