BEUDAMED
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    Filters Classification: Class I × Status: Ongoing × Clear all

    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

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    FDA Enforcement
    Class I ·Ongoing·Universal Meditech Inc.·February 8, 2023