BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    FILLISCOPE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159525·PROTECT.EPI ELBOW SUPPORT GRAY IV

    UROMAX ULTRA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 16, 2010

    BELT CLIP MMT-640CL PUMP CLEAR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 12, 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