BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    KARL STORZ FLUID LIGHT CABLES

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

    NOVA LITE TM THYROID

    FDA 510(k)
    FDA Class 2 ·Immunology

    EIXO THERMUS HEATING PADS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SPIROBAC FILTER REINF MEMBRANE

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code CAH·August 1, 2012

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 2010

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·January 10, 2013

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 18, 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