BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Planmed Clarity

    FDA 510(k)
    FDA Class 2 ·Radiology

    REVEAL LINQ

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code DSI·June 10, 2014

    N/A

    FDA Adverse Event
    Malfunction ·ASCENT·Product code NLQ·October 9, 2010

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·December 10, 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