BEUDAMED
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    ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

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

    CAMLAB CRANIAL ORTHOSIS HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    SURGISTOOL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FZM·June 18, 2014

    HUDSON NASAL CANNULA, OVER-THE-EAR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZD·October 8, 2010

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·November 7, 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