BEUDAMED
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    PLANCON MIRCOLAMELLAR KERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CRYO, MODEL V6.0

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PHOTOMETER, SEROMETER (MODEL 380)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STELLANT SYRINGE KIT

    FDA Adverse Event
    Malfunction ·MEDRAD·Product code DXT·January 25, 2013

    UNKNOWN

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code MOS·December 16, 2010

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·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