BEUDAMED
    2 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    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

    Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·June 3, 2026