Integrated Continuous Glucose Monitoring system, factory calibrated
FDA product code QBJ · Class 2 · 62 devices · 1,155,229 reports · 19 deaths reported · 18 devices named in recalls
- Dexcom G6 Transmitter 9445-24Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated240,475 reports
- Dexcom G6 Transmitter 9445-02Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 deaths229,493 reports
- Dexcom G6 Sensor Applicator Assembly 9500-45Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall4 deaths114,678 reports
- US G6 Transmitter (Retail, Receiver Optional) STT-OE-002Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated76,977 reports
- Dexcom G7 GSS (161) 9500-161Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated70,146 reports
- Dexcom G7 iOS App SW12300Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 recalls1 death55,219 reports
- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
- G6 Medicare Transmitter STT-OM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated38,339 reports
- FreeStyle Libre 3 Plus 78768Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated1 death33,035 reports
- Dexcom G7 GSS (160) 9500-160Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated33,025 reports
- Dexcom G7 Android App SW12299Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall28,569 reports
- Dexcom G6 iOS SW11677Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall23,526 reports
- Dexcom G7 Receiver STK-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall3 deaths21,449 reports
- US G6 Transmitter STT-OR-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated19,514 reports
- FreeStyle Libre 3 Plus 78768Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1 death18,890 reports
- Dexcom G7 GSS (161) STP-AT-013Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated16,695 reports
- Dexcom G6 Receiver MT24078Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall15,819 reports
- Dexcom G7 GSS 9500-151Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated12,714 reports
- Dexcom G7 Receiver STK-AT-013Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall9,330 reports
- Dexcom G7 GSS 9500-155Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated7,118 reports
- Dexcom G7 GSS (161) STP-AT-011Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated6,223 reports
- Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated5,305 reports
- Dexcom G6 Android SW11678Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1 death4,055 reports
- Dexcom G7 Receiver STK-AT-011Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall2,939 reports
- Dexcom G6 Receiver STK-OE-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall2,845 reports
- Dexcom G6 Sensor Kit (1) Medicare STS-OM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated2,371 reports
- Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-013Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated2,030 reports
- Dexcom G6 Receiver Kit STK-OR-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1,969 reports
- FreeStyle Libre 2 Plus 78747Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated1,833 reports
- Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-010Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1,527 reports
- Dexcom G7 Sample Pack (161) STE-AT-030Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1,447 reports
- Dexcom G6 Receiver STK-FR-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall1,373 reports
- FreeStyle Libre 2 Plus 78747Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated1,337 reports
- Dexcom G7 GSS (1) STP-AT-018Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated939 reports
- Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STE-FT-016Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated912 reports
- Instinct 78893Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated892 reports
- Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-011Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated627 reports
- Dexcom G6 Receiver STK-FM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall483 reports
- FreeStyle Libre 3 Plus 78769Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated1 recall472 reports
- Dexcom G7 GSS (155) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated406 reports
- FreeStyle Libre 3 Plus 78769-01Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated367 reports
- Dexcom G7 iOS Watch App SW13355Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated2 recalls255 reports
- Dexcom G7 GSS (160) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated317 reports
- FreeStyle Libre 3 72079Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated315 reports
- Dexcom G6 Receiver STK-FE-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated191 reports
- Dexcom G7 GSS (155) STP-AT-013Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated182 reports
- Dexcom G7 GSS (160) STP-AT-013Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated165 reports
- Dexcom G7 GSS STP-AT-011Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated65 reports
- Dexcom G7 GSS (160) STP-AT-011Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated51 reports
- Dexcom Discovery Sensor 3 Pack STS-DE-003Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall0 reports
- FreeStyle Libre 3 Plus 78769Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated44 reports
- Dexcom G7 Sample Pack (155) STE-AT-030Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated34 reports
- FreeStyle Libre 2 Plus 78749Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated17 reports
- Dexcom G7 Receiver MT26403-0Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated14 reports
- Dexcom G7 GSS STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated13 reports
- Dexcom G7 Sample Pack (160) STE-AT-030Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated11 reports
- FreeStyle Libre 2 Plus 78749Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated5 reports
- FreeStyle Libre 3 78754Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated2 reports
- US G6 Pro Reader Kit STK-RD-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated2 reports
- FreeStyle Libre 3 72078Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated1 report
- Libre App 78745-01Abbott Diabetes Care Inc · Integrated Continuous Glucose Monitoring system, factory calibrated1 report
- Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System 9510Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 report