BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    DRI Cocaine Metabolite Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BIOPRO HEMI-EDGE TOE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    INTEGRIS ALLURA 9

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·August 10, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2013

    ENDOPOUCH RETRIEVER SPEC BAG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·November 9, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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