BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    FlexGard Cut-Resistant Glove Liners

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

    NOVEL ALIF SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XVAC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 7, 2008

    FORCETRIAD ENERGY PLATFORM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·June 14, 2013

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·July 26, 2011

    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