BEUDAMED
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    DISPOS. SCOTT CANNULAS 16-1054 ETC.

    FDA 510(k)
    FDA Class 2 ·Neurology

    CARDIOMEMO III

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEMAND ANALYZER SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 17, 2014

    ASR XL TAP SLV ADAP 12/14+5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·September 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