BEUDAMED
    10,000 results · 118ms · 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 Regulation: Us FDA ×

    FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code QLG·June 12, 2024

    FREESTYLE LIBRE 2 BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE, INC.·Product code QLG·September 7, 2022

    FREESTYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code QLG·September 23, 2024

    FREESTYLE LIBRE 14 DAY

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023

    LIBRE BLOOD SUGAR MONITOR

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code QLG·August 7, 2024

    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·February 13, 2023

    FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·July 12, 2023

    FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

    FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·July 24, 2024

    FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

    FDA Recall
    Open, Classified ·Cardinal Health Inc.·Product code QLG·March 16, 2021

    Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.

    FDA Recall
    Open, Classified ·BIGFOOT BIOMEDICAL·Product code QLG·May 21, 2025

    FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

    FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

    FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

    FDA Recall
    Open, Classified ·Abbott Diabetes Care, Inc.·Product code QLG·November 24, 2025

    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

    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

    FDA classification
    FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

    LIBRE 2 SENSOR FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·April 20, 2021

    LIBRE 2 SENSOR FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·May 6, 2021

    LIBRE 2 SENSOR FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·June 29, 2021

    FREESTYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code QLG·May 27, 2021