BEUDAMED
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    PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    G.E. MSI 850/850II/1250 THREE PHASE GENERATORS

    FDA 510(k)
    FDA Class 1 ·Radiology

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 7, 2013

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2011

    CAPSURE SENSE

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    INFUSOMAT SPACE PUMP IV SET

    FDA Adverse Event
    Malfunction ·B. BRAUN DOMINICAN REPUBLIC·Product code FPA·November 17, 2009

    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