BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    CK-MB/LD-1 CONTROL SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EBV(EPSTEIN-BARR VIRUS) TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO

    FDA 510(k)
    FDA Class 2 ·Immunology

    12.0MM/8.0MM PROTECTION SLEEVE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code LXH·June 25, 2014

    5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GCJ·November 2, 2010

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 3, 2013

    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