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
Cleared
Aug 17, 2021
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Chemistry
308d
Cleared
Jul 15, 2021
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Chemistry
422d
Cleared
Dec 04, 2020
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
Chemistry
247d
Cleared
Jan 29, 2020
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
Chemistry
30d
Cleared
Oct 25, 2019
Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
Chemistry
25d
Cleared
Oct 07, 2019
Dexcom G6 Pro Continuous Glucose Monitoring System
Chemistry
90d
Cleared
Jun 28, 2019
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
Chemistry
28d
Cleared
Feb 14, 2019
Dexcom G6 Continuous Glucose Monitoring System
Chemistry
87d
Cleared
Nov 02, 2018
Dexcom Pro Q Continuous Glucose Monitoring System
Chemistry
59d
Cleared
Oct 26, 2018
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Chemistry
88d
Not Cleared
Mar 27, 2018
Dexcom G6 Continuous Glucose Monitoring System
Chemistry
109d
Not Cleared
Jan 23, 2015
Dexcom Share Direct Secondary Displays
Chemistry
39d
Not Cleared
Aug 19, 2014
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
Chemistry
119d