BEUDAMED
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    MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Hi-Dow Wireless TENS/EMS System (Model HD-5N)

    FDA 510(k)
    FDA Class 2 ·Neurology

    SMALL STATURE SPACERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 19, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTN·February 15, 2013

    UNKNOWN BIO-INTRAFIX SCREW

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·January 14, 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