BEUDAMED
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    Quantidex qPCR BCR-ABL IS Kit

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    SENTINEL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code PUM·October 10, 2025

    XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TEPHAFLEX ABSORBABLE SUTURE

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

    SENTINEL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code PUM·September 8, 2025

    BD MAX¿ VAGINAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PQA·October 5, 2022