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

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    Disposable Dual Action Tissue Closure Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Omnipod 5 SmartBolus Calculator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SHIRAZ-JAVA SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·July 21, 2022

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·November 6, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 3, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 22, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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