127 results
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31ms
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Sources: EU EUDAMED, US FDA
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BIGFOOT BIOMEDICAL,.INC·Product code QLG·November 9, 2023
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BIGFOOT BIOMEDICAL, INC·Product code QLG·September 15, 2022
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BIGFOOT BIOMEDICAL, INC·Product code QLG·October 12, 2022
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BIGFOOT BIOMEDICAL, INC·Product code QLG·July 21, 2022
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BIGFOOT BIOMEDICAL, INC.·Product code QLG·March 20, 2022
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BIGFOOT BIOMEDICAL, INC.·Product code QOG·February 22, 2022
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 Enforcement
Class II
·Ongoing·BIGFOOT BIOMEDICAL·July 2, 2025