Tandem Diabetes Care, Inc. - FDA 510(k) Cleared Devices
24
Total
22
Cleared
2
Denied
FDA 510(k) cleared devices by Tandem Diabetes Care, Inc. Chemistry ✕
16 devices
Cleared
Nov 06, 2025
Tandem Mobi insulin pump with interoperable technology
Chemistry
44d
Cleared
Sep 24, 2025
t:slim X2 insulin pump with interoperable technology
Chemistry
194d
Cleared
May 21, 2025
Control-IQ+ technology
Chemistry
68d
Cleared
Feb 24, 2025
Control-IQ+ technology
Chemistry
74d
Cleared
Jul 26, 2024
Tandem Mobi Insulin Pump with interoperable technology
Chemistry
98d
Cleared
Mar 21, 2024
Tandem Mobi insulin pump with interoperable technology
Chemistry
48d
Cleared
Nov 03, 2023
t:slim X2 Insulin Pump with Interoperable Technology
Chemistry
87d
Cleared
Nov 03, 2023
Control-IQ Technology
Chemistry
87d
Cleared
Oct 05, 2023
Tandem Mobi insulin pump with interoperable technology
Chemistry
10d
Cleared
Jul 10, 2023
Tandem Mobi Insulin Pump with Interoperable Technology
Chemistry
266d
Cleared
Feb 15, 2022
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
Chemistry
469d
Cleared
Jun 16, 2020
Control-IQ Technology
Chemistry
111d