BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Medical nitrile examination gloves (Model: JL001)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZENITH AAA ENDOVASCUALR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·November 12, 2008

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 4, 2011

    3M FILTEK SP (ESPE)

    FDA Adverse Event
    Injury ·3M CENTER·Product code EBF·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

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025