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Dexcom, Inc.

FDA 510(k) & PMA Approved Devices — 26 products

Total Devices26
Categories8
Latest FDA decision2026-08-11
TypeNumberDevice NameCodeDateActions
510(k) K262472 Stelo Glucose Biosensor SystemSBH2026-08-11 View
510(k) K260935 Stelo Glucose Biosensor SystemSBH2026-06-12 View
510(k) K261402 Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ2026-06-08 View
510(k) K261359 Stelo Glucose Biosensor SystemSAF2026-05-21 View
510(k) K253737 Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemQBJ2026-02-03 View
510(k) K253710 Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemQBJ2025-12-17 View
510(k) K252818 Dexcom Smart BasalQRX2025-11-18 View
510(k) K243214 Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ2025-04-09 View
510(k) K240902 Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-04-23 View
510(k) K234070 Stelo Glucose Biosensor SystemSAF2024-03-05 View
510(k) K234133 Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-02-26 View
PMA P120005 Sensor, glucose, invasiveMDS2024-01-09 View
510(k) K231081 Dexcom G7 Continuous Glucose Monitoring (CGM) SystemQBJ2023-05-15 View
510(k) K223931 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ2023-01-11 View
510(k) K213919 Dexcom G7 Continuous Glucose Monitoring SystemQBJ2022-12-07 View
510(k) K221259 Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) SystemQBJ2022-07-29 View
510(k) K203089 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemQDK2021-08-17 View
510(k) K201328 Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ2021-07-15 View
510(k) K200876 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemQBJ2020-12-04 View
510(k) K193642 Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemQDK2020-01-29 View

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Related Clinical Trials

NCT06601166CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on InsulinACTIVE_NOT_RECRUITINGNCT07603284Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi ArabiaACTIVE_NOT_RECRUITINGNCT07681024Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)NOT_YET_RECRUITINGNCT07681375Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 SensorACTIVE_NOT_RECRUITINGNCT04261738Effects of HBO on Glucose in Patients With DMTERMINATEDNCT04386005Continuous Glucose Monitoring in At-Risk NewbornsCOMPLETEDNCT05360056Continuous Glucose Monitoring Following Hospital DischargeACTIVE_NOT_RECRUITINGNCT06297850Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational StudyCOMPLETEDNCT06314061The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes.COMPLETEDNCT06357728Continuous Glucose Monitoring Glycemic cHAracterization During PregnancyRECRUITING
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