BEUDAMED
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    VISITEC EYE SPECULUM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    syngo.CT Lung CAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·June 2, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·November 21, 2012

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·September 23, 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