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Tandem Diabetes Care, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K260429 Control-IQ+ technologyQJI2026-04-24 View
510(k) K253074 Tandem Mobi insulin pump with interoperable technologyQFG2025-11-06 View
510(k) K250792 t:slim X2 insulin pump with interoperable technologyQFG2025-09-24 View
510(k) K250798 Control-IQ+ technologyQJI2025-05-21 View
510(k) K243823 Control-IQ+ technologyQJI2025-02-24 View
510(k) K241078 Tandem Mobi Insulin Pump with interoperable technologyQFG2024-07-26 View
510(k) K240309 Tandem Mobi insulin pump with interoperable technologyQFG2024-03-21 View
510(k) K232380 t:slim X2 Insulin Pump with Interoperable TechnologyQFG2023-11-03 View
510(k) K232382 Control-IQ TechnologyQJI2023-11-03 View
510(k) K233044 Tandem Mobi insulin pump with interoperable technologyQFG2023-10-05 View
510(k) K223213 Tandem Mobi Insulin Pump with Interoperable TechnologyQFG2023-07-10 View
510(k) K203234 t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)QFG2022-02-15 View
510(k) K200467 Control-IQ TechnologyQJI2020-06-16 View
510(k) K201214 t:slim X2 Insulin Pump with Interoperable TechnologyQFG2020-06-04 View
510(k) K193483 Basal-IQ TechnologyQJS2020-02-28 View
510(k) K162080 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterLZG2016-10-25 View
510(k) K160056 t:slim Insulin Delivery SystemLZG2016-07-25 View
510(k) K160482 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterLZG2016-07-13 View
510(k) K122361 T:CONNECT DATA MANAGEMENT SYSTEMOUG2013-02-22 View
510(k) K111210 T:SLIM (TM) INSULIN DELIVERY SYSTEMLZG2011-11-09 View
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