BEUDAMED
    6 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Lenire Tinnitus Treatment Device

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

    NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable

    FDA 510(k)
    FDA Class 2 ·Neurology

    SureTune4 Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    NIGHTWARE

    FDA Adverse Event
    Injury ·NIGHTWARE INC.·Product code QMZ·February 28, 2023

    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