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

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    Portable oxygen concentrator (JLO-190P)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011252616200·ceraMotion® Me 3D Dentin CC3+2, 20 g / dental c...

    Vu ePOD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981048860·26mm Trial, 5 Deg, 16 mm

    Koios DS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ClearCap Distal Attachment

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    IVT DISPOSABLES

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011

    POLYHESIVE RETURN ELECTRODE

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·July 15, 2013

    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