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

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    CUTTER TUNGSTEN CARBIDE BURS

    FDA 510(k)
    FDA Class 1 ·Dental

    CLEANSING AGENT, NEW WOUND (DEBRISSU)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NxStage System One Plus

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

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 12, 2007

    HEARTSTART MRX AIRWORTHY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 5, 2014

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·October 3, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014

    ACCOLADE SR SL MRI (Model L310)

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