BEUDAMED
    7 results · 24ms · Sources: EU EUDAMED, US FDA

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    AMPLIFIER OTRONA, MODEL N3A-EMG

    FDA 510(k)
    FDA Class 2 ·Neurology

    EPIVISION SL SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HERSHMAN LENS FORCEPS W/OUT IRRIGATOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BIOTENE ORALBALANCE GEL (2013 FORMULATION)

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code LFD·April 3, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 27, 2007

    APPLICATOR INNER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·October 4, 2012

    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