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

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    LED Curing Lights (DB686 HALO)

    FDA 510(k)
    FDA Class 2 ·Dental

    Access CEA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Microthin Natural Rubber Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 23, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code DRO·November 23, 2015

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025