BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    ONE Male Condom

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

    EaseVRx

    FDA 510(k)
    FDA Class 2 ·Neurology

    Zuno Smart Sterilization Container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPECTRANETICS 16F CAVACLEAR LASER SHEATH

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

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Malfunction ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·August 6, 2024

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Malfunction ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·November 14, 2025

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Malfunction ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·October 29, 2025

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Malfunction ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·November 17, 2025

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Malfunction ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·December 1, 2023

    CAVACLEAR LASER SHEATH

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

    CAVACLEAR LASER SHEATH

    FDA Adverse Event
    Malfunction ·PHILIPS IMAGE GUIDED THERAPY CORPORATION·Product code QRJ·July 23, 2024

    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