BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    Reaxon Plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    ORTHOPHOS XG 3D / CEPH

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIME-LITE II

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 3, 2011

    PROLIEVE THERMODILATATION KIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 29, 2008

    POWERHEART G5 AUTOMATIC AED

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018

    EAGLE EYE PLATINUM SHORT TIP

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025