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

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    CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER

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

    DERMACARE SYNTHETIC MEDICAL GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MENTOR EEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE-NORTH AMERICA·Product code KDI·May 16, 2008

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORK, LTD·Product code HCG·February 5, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 3, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 18, 2014

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 16, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 16, 2024

    ALTIS KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code PAH·August 30, 2018

    ALTIS KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code PAH·September 15, 2016

    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