BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    IVX Fluid Transfer Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Unity

    FDA UDI
    DIOMEDICAL CO.,LTD.·08800039821629·SIJ Lag ScrewOD12.5xL30

    3DI INCLUDING CSCORE

    FDA 510(k)
    FDA Class 2 ·Radiology

    AA-1 SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021

    APEX¿

    FDA Adverse Event
    Malfunction ·B. BRAUN AVITUM ITALY S.P.A.·Product code KPE·April 6, 2026

    840 VENTILATOR

    FDA Adverse Event
    Death ·PURITAN-BENNETT CORP.·Product code CBK·October 24, 2008

    MEDFUSION HI-FLO

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC·Product code FMG·August 2, 2011

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 9, 2013

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023