BEUDAMED
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    TESTOTERONE ELISA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PORTABLE VENTILATOR PATIENT CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Arthrex Univers Revers Modular Glenoid System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 19, 2013

    STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code LJH·August 1, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·January 20, 2011

    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