BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000

    FDA 510(k)
    FDA Class 2 ·Neurology

    Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 14, 2014

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·September 17, 2011

    UNK

    FDA Adverse Event
    Injury ·CELLESTIS INC·Product code NCD·July 10, 2013

    ACCOLADE DR SL MRI (Model L311)

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