BEUDAMED
    5 results · 26ms · Sources: EU EUDAMED, US FDA

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    APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Sunrise Sleep Disorder Diagnostic Aid

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Luminopia One

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·May 6, 2026

    Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code QYV·March 23, 2026