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

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    GI Genius

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

    ISOAMP HSV ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EZ SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    LERADO GLOBAL·Product code ILS·July 8, 2013

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026