BEUDAMED
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    SCHULTZ PHALANGEAL COMPONENT DRIVER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    TRIAL CABLE, 3009

    FDA 510(k)
    FDA Class 2 ·Neurology

    EchoPAC Software Only, EchoPAC Plug-in

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·June 12, 2014

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·October 6, 2010

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 12, 2012

    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