BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813058220·STERILE CARBDE BUR EF310BLADE DARBY

    ATRICURE ISOLATOR TRANSPOLAR PEN

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

    FloSure Ventilation Patch

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

    QUADRA R FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·March 30, 2026

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 15, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014

    PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·July 12, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013