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

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    Filters Regulation: Us FDA ×

    Carestation 750/750c

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    XIVE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    LACRICATH LACRIMAL DUCT CATHETER

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 24, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·October 6, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 5, 2011

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·July 3, 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