FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K222447 |
Abbott Diabetes Care Inc. |
FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System |
03/03/2023 |
K223435 |
Abbott Diabetes Care Inc. |
FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System |
04/13/2023 |
K201328 |
Dexcom, Inc. |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
07/15/2021 |
K223931 |
Dexcom, Inc. |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
01/11/2023 |
K221259 |
Dexcom, Inc. |
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System |
07/29/2022 |
K183206 |
Dexcom, Inc. |
Dexcom G6 Continuous Glucose Monitoring System |
02/14/2019 |
DEN170088 |
Dexcom, Inc. |
Dexcom G6 Continuous Glucose Monitoring System |
03/27/2018 |
K200876 |
Dexcom, Inc. |
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System |
12/04/2020 |
K191450 |
Dexcom, Inc. |
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System |
06/28/2019 |
K231081 |
Dexcom, Inc. |
Dexcom G7 Continuous Glucose Monitoring (CGM) System |
05/15/2023 |
K213919 |
Dexcom, Inc. |
Dexcom G7 Continuous Glucose Monitoring System |
12/07/2022 |