BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PORTA. X-RAY UNIT FP220 SCM-1-ETC,

    FDA 510(k)
    FDA Class 2 ·Radiology

    K883239

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2009

    CAPD DISP DISCONNECT, UV FLASH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008

    ZOLL E SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OPTIBOND XTR

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code KLE·May 27, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 15, 2012

    UNKNOWN DEPUY PINNACLE CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·September 9, 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