BEUDAMED
    3 results · 7ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

    FDA Enforcement
    Class II ·Ongoing·Sonendo Inc·November 23, 2022

    Welch Allyn CONNEX Accessory Power Management Stand:

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 23, 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