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

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    BrightMatter Guide with Surface Trace Registration

    FDA 510(k)
    FDA Class 2 ·Neurology

    MRI SYTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HENRY SCHEIN/ACCLEAN

    FDA Adverse Event
    Malfunction ·GLOBAL DENT AIDS PRIVATE LIMITED·Product code EFW·September 5, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

    EEA 31MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·September 8, 2008

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 30, 2011

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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