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

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    Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELPHA 4 CONTI

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

    VITAL COUGH

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ALARIS SYSTEM

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

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 6, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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