BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    AEROSOL DELIVERY HOOD

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    KardiaMobile, KardiaStation

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 18, 2014

    SPACELABS MCARE VITAL SIGNS MONITOR

    FDA Adverse Event
    SPACELABS HEALTHCARE·Product code MHX·October 20, 2010

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 20, 2012

    Basic Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015