BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    RC-SwiftPrep

    FDA 510(k)
    FDA Unclassified ·Unknown

    ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

    FDA 510(k)
    FDA Class 2 ·Immunology

    AXS-1 LITE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·September 15, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 6, 2014

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·June 4, 2015

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013