Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
FDA product code QLG · Class 2 · 30 devices · 40,329 reports · 2 deaths reported · 12 devices named in recalls
- FreeStyle Libre 2 71992Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems1 death23,063 reports
- FreeStyle Libre 3 72081Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems2 recalls16,326 reports
- FreeStyle Libre 2 72000Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems453 reports
- FreeStyle Libre 3 72080Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems1 recall274 reports
- FreeStyle Libre 2 71951Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems2 recalls72 reports
- FreeStyle Libre 3 App 72075-01Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems1 recall23 reports
- Bigfoot Unity Diabetes Management System ASM-10046Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall12 reports
- Bigfoot Unity Diabetes Management System ASM-10053Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall0 reports
- Bigfoot Unity Diabetes Management System FG-300171Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall0 reports
- Bigfoot Unity Diabetes Management System FG-300173Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall0 reports
- Bigfoot Unity Diabetes Management System FG-300174Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall0 reports
- Bigfoot Unity Diabetes Management System FG-300175Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall0 reports
- Bigfoot Unity Diabetes Management System FG-300176Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall0 reports
- Bigfoot Unity Diabetes Management System FG-300179Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 recall0 reports
- FreeStyle Libre 3 App 72077-01Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems41 reports
- FreeStyle Libre 2 App 71926-01Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems21 reports
- Bigfoot Unity Diabetes Management System ASM-10027Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems13 reports
- Bigfoot Unity Diabetes Management System FG-300188Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems5 reports
- Bigfoot Unity Diabetes Management System ASM-10048Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 death4 reports
- Bigfoot Unity Diabetes Management System FG-300185Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems4 reports
- Bigfoot Unity Diabetes Management System FG-300200Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems3 reports
- Bigfoot Unity Diabetes Management System FG-300206Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems3 reports
- Libre App 78746-01Abbott Diabetes Care Inc · Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems2 reports
- Bigfoot Unity Diabetes Management System ASM-10049Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2 reports
- Bigfoot Unity Diabetes Management System FG-300186Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2 reports
- Bigfoot Unity Diabetes Management System FG-300204Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2 reports
- Bigfoot Unity Diabetes Management System FG-300187Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 report
- Bigfoot Unity Diabetes Management System FG-300202Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 report
- Bigfoot Unity Diabetes Management System FG-300203Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 report
- Bigfoot Unity Diabetes Management System FG-300205Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems1 report