BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    URight Hemoglobin A1c system, FORA A1c System

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMA SCREEN ER

    FDA 510(k)
    FDA Class 2 ·Hematology

    LPS UPPER EXTREMITY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAST CUTTER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAB·June 3, 2013

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 21, 2011

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·August 29, 2008

    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

    FDA Enforcement
    Class II ·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024