BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    Sunrise Sleep Disorder Diagnostic Aid

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

    EEVA 2.0

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SPECTRANETICS 16F CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code QRJ·November 21, 2022

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Injury ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·February 19, 2025

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Injury ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·March 5, 2025

    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