BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    IV START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SEKURIT SHARPS COLLECTION CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICROMED QRS CARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STELLARIS 25GS COMBINATION PACK W V&AFI&WF

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·June 19, 2014

    C-QUR TACSHIELD

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP.·Product code FTL·January 2, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·December 22, 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