BEUDAMED
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    THERAPAX DXT 300 SERIES 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNGO, CT BONE READING

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASCENSIA DEX 2 DIABETES CARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 22, 2013

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·December 8, 2010

    2CM PERIPHERAL CUTTING BALLOON?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·July 9, 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