BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    Medical Thulium Fiber Laser Systems (UroFiber 60Q)

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

    Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERSATAP SUTURE ANCHOR

    FDA Adverse Event
    Malfunction ·ORTHO-DESIGN·Product code MBI·September 15, 2025

    BECKMAN COULTER ¿ COULTER ® LH 750 (SLIDER MAKER ) HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·September 10, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

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