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    KLEENSPEC

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704265651·

    DYRACT CEM PLUS CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PCA EMPTY STERILE

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code MEA·January 31, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 16, 2010

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 17, 2014

    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