5 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
FDA Enforcement
Class II
·Ongoing·Abbott Diabetes Care, Inc.·August 23, 2023
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
FDA Enforcement
Class II
·Terminated·Abbott Diabetes Care, Inc.·April 1, 2020
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
FDA Enforcement
Class II
·Terminated·Abbott Diabetes Care, Inc.·April 1, 2020
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
FDA Enforcement
Class II
·Terminated·Abbott Diabetes Care, Inc.·April 1, 2020
FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System
FDA Enforcement
Class II
·Completed·Abbott Diabetes Care, Inc.·January 24, 2024