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

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    Dermal Cooling System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SCANVIEW, MODEL SC-300

    FDA 510(k)
    FDA Class 2 ·Hematology

    STEREOS WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Z-LOOK3

    FDA Adverse Event
    Injury ·Z-SYSTEMS AG·Product code DZE·June 15, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·June 30, 2011

    MATTRIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·September 17, 2008

    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