BEUDAMED
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    KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS

    FDA 510(k)
    FDA Class 2 ·Hematology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209118311·

    SUNCO Mechanical Wheelchair, model SKW-9003

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BIOSPLINT SPLINTING RIBBON

    FDA 510(k)
    FDA Class 2 ·Dental

    SMARTSET MV 40G - EO

    FDA Adverse Event
    Injury ·DEPUY CMW 9610921·Product code LOD·June 6, 2014

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 30, 2012

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code MNB·September 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