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

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    NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    T-Cuff

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ARTHREX ASPIRATE KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CARELINK

    FDA Adverse Event
    Injury ·PLEXUS MANUFACTURING SDN. BHD·Product code NVZ·June 10, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD .·Product code MCM·December 10, 2012

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2010

    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