BEUDAMED
    8 results · 28ms · 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 ×

    ULCERCARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756300414·PLIF TRAY

    Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)

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

    IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 24, 2014

    NUROLON NYLON SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAR·November 3, 2010

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·January 2, 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