BEUDAMED
    3 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    One Step K in vitro diagnostic test REF: 81A4

    FDA Enforcement
    Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

    GE HealthCare OEC 9800.

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·September 3, 2025

    GE HealthCare OEC 9900 Elite C-arm Systems.

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·September 3, 2025