BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    DEX Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GE LOGIQ P5 MODEL H44662LD

    FDA 510(k)
    FDA Class 2 ·Radiology

    OSSEOLINK DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    INSYTE-N AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 15, 2025

    INSYTE-N AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2025

    INSYTE-N AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 14, 2025

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code GEI·October 1, 2008

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 27, 2013

    WALLSTENT-UNI¿ ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code JCT·August 4, 2011

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024