BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    LASE SYSTEM II

    FDA 510(k)

    LiveMedica Enterprise PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BACTEC PEDS PLUS/ F CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 14, 2021

    HEARTSMART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 15, 2010

    SAGITTAL SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·July 23, 2014

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020