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

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    DIAZO COLORIMETRY, BILLIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Origio Gas Line Filter

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTIBOND XTR

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

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 14, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 13, 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