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

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    BLANKET, BURN

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NexxZr Plus Multi 2.0 B1 W98-16mm

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271158444·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110607·COAXIAL IRRIGAT-ASPIRAT TIP 160 DEG SIDE

    APEXCAL

    FDA 510(k)
    FDA Class 2 ·Dental

    BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

    FDA Adverse Event
    Injury ·Product code JXG·April 20, 2014

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 26, 2012

    TECNIS CL

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·July 18, 2010

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025