Dexcom, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Stelo Glucose Biosensor System, Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
27
Total
24
Cleared
3
Denied
FDA 510(k) Regulatory Record - Dexcom, Inc. Chemistry ✕
25 devices
Cleared
Jun 12, 2026
Stelo Glucose Biosensor System
Chemistry
84d
Cleared
Jun 08, 2026
Dexcom G7 Continuous Glucose Monitoring System
Chemistry
40d
Cleared
CT
May 21, 2026
Stelo Glucose Biosensor System
Chemistry
27d
Cleared
Feb 03, 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System
Chemistry
71d
Cleared
Dec 17, 2025
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day...
Chemistry
23d
Cleared
Nov 18, 2025
Dexcom Smart Basal
Chemistry
75d
Cleared
CT
Apr 09, 2025
Dexcom G7 15 Day Continuous Glucose Monitoring System
Chemistry
188d
Cleared
CT
Mar 05, 2024
Stelo Glucose Biosensor System
Chemistry
74d
Cleared
May 15, 2023
Dexcom G7 Continuous Glucose Monitoring (CGM) System
Chemistry
28d
Cleared
Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Chemistry
12d
Cleared
Dec 07, 2022
Dexcom G7 Continuous Glucose Monitoring System
Chemistry
357d
Cleared
Jul 29, 2022
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose...
Chemistry
88d