BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    FreeStyle Libre 3 Continuous Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044208139·SPUTOCOL SPUTUM COLLECT CONCL

    RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 7, 2025

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR/SENSOR

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·October 20, 2008

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·June 23, 2011

    GYNECARE PROLIFT +M TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019