BEUDAMED
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    CINE CAMERA CONTROL MODEL PK2037

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGICAL DRILLS

    FDA 510(k)
    FDA Class 2 ·Dental

    DIRECTIGEN1-2-3 BHCG PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM (SLC)·Product code JAA·May 19, 2014

    ASR ACETABULAR IMPLANT 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 4, 2013

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 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