BEUDAMED
    4 results · 13ms · 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 Status: Completed ×

    Elekta Unity

    FDA Enforcement
    Class II ·Completed·Elekta Limited·January 16, 2019

    Elekta Unity

    FDA Recall
    Completed ·Elekta Limited Linac House Fleming Way Crawley United Kingdom·Product code IYE·January 4, 2019

    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

    FDA Recall
    Completed ·Abbott Diabetes Care, Inc.·Product code QLG·February 9, 2023

    Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

    FDA Recall
    Completed ·Obalon Therapeutics Inc·Product code LTI·May 23, 2019