5 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Completed
×
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JIX·October 29, 2020
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