BEUDAMED
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    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

    FDA Enforcement
    Class I ·Ongoing·Given Imaging Ltd.·July 16, 2025

    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

    FDA Enforcement
    Class I ·Ongoing·MEDTECH SAS·November 3, 2021