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Tandem Diabetes Care, Inc. FDA Approvals

0 new drug approvals and 12 device clearances on file. Matched by name to TNDM.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Control-IQ+ technology510(k)Apr 24, 2026Clinical Chemistry
Tandem Mobi insulin pump with interoperable technology510(k)Nov 6, 2025Clinical Chemistry
t:slim X2 insulin pump with interoperable technology510(k)Sep 24, 2025Clinical Chemistry
Control-IQ+ technology510(k)May 21, 2025Clinical Chemistry
Control-IQ+ technology510(k)Feb 24, 2025Clinical Chemistry
Tandem Mobi Insulin Pump with interoperable technology510(k)Jul 26, 2024Clinical Chemistry
Tandem Mobi insulin pump with interoperable technology510(k)Mar 21, 2024Clinical Chemistry
Control-IQ Technology510(k)Nov 3, 2023Clinical Chemistry
t:slim X2 Insulin Pump with Interoperable Technology510(k)Nov 3, 2023Clinical Chemistry
Tandem Mobi insulin pump with interoperable technology510(k)Oct 5, 2023Clinical Chemistry
Tandem Mobi Insulin Pump with Interoperable Technology510(k)Jul 10, 2023Clinical Chemistry
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)510(k)Feb 15, 2022Clinical Chemistry

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