BEUDAMED
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    Interson USB Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGHTCYCLER INSTRUMENT VERSION 1.2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SEAL SINGLE-USE BIOPSY VALVE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JGS·September 3, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·July 9, 2013

    NONTEMPLATE ALIGNER ARCH

    FDA Adverse Event
    Injury ·DENTSPLY SIRONA ORTHODONTICS INC.·Product code NXC·May 16, 2024

    LOGIC CR TIB INSERT SLOPE++, SZ 4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 23, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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