7 results
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31ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care, Inc.·April 1, 2026
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor; Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care, Inc.·October 29, 2025
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care, Inc.·October 1, 2025
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care Inc·June 22, 2022
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care Inc·July 25, 2018
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care Inc·October 5, 2022
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
FDA Enforcement
Class II
·Ongoing·Tandem Diabetes Care Inc·October 5, 2022