BEUDAMED
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    OPUS HLH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    P.F.C. SIGMA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295245056·P.F.C. SIGMA STABILIZED PLUS TIBIAL INSERT TRIA...

    PEAK EXPIRATORY FLOW METER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·June 13, 2014

    PATELLA CLAMP

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 22, 2010

    RADIOLUCENT DRIVE DRILL BIT

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·February 15, 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