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

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    MCINTYRE SURGICAL GONIOLENS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PIGGYBACK WIRE CONVERTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Navina Smart System, Navina Classic System

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

    SP2 TIBIAL RADEL IMPACTOR

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·June 24, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 29, 2010

    ALLEGRETTO WAVE

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·December 21, 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