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

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    ALBUMIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR

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

    ARIS TRANS-OBTURATOR

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FTL·January 30, 2014

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 20, 2012

    BATTERY RECIPROCATOR II HANDPIECE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·June 12, 2015

    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