BEUDAMED
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    POST-AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LEECH, MEDICINAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    ARTHREX SMALL FRAGMENT PLATES AND SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code BTI·May 30, 2014

    HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS

    FDA Adverse Event
    Injury ·SYNTHES·Product code HTO·November 20, 2012

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·September 15, 2010

    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