BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Ingenia 1.5T CX and Ingenia 3.0T CX R5.3

    FDA 510(k)
    FDA Class 2 ·Radiology

    BI-METRIC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304254367·

    IMPLUS IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    G-CINCH SUTURE GRASPER

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

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·June 11, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·July 15, 2011

    PROTECTA XT DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·October 10, 2014

    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