BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GIRAFFE2

    FDA 510(k)
    FDA Unclassified ·Unknown

    AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013

    STERLING MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DQY·September 18, 2008

    COULTER LH750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 15, 2011

    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