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

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    VIRGO AMA ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    HAL for Medical Use (Lower Limb Type)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R

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

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 18, 2013

    ARCHITECT TOXO IGM

    FDA Adverse Event
    Malfunction ·ABBOTT·Product code LGD·January 27, 2011

    PX SLIM DELIVERY MICROCATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·July 31, 2014

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    FDA Adverse Event
    Malfunction ·EES-JUAREZ·Product code GAG·April 2, 1997

    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