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

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    Auxano® Wedge Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 17, 2022

    Ez3D-i/E3

    FDA 510(k)
    FDA Class 2 ·Radiology

    Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 30, 2024

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 14, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 31, 2011

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code HIH·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

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