33 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198
FDA Enforcement
Class I
·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 12, 2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 20, 2024
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·July 19, 2023
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin 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). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081
FDA Enforcement
Class I
·Ongoing·Tandem Diabetes Care, Inc.·November 12, 2025
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·December 30, 2020
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
iQ 2 Nasal Vented Mask
FDA Enforcement
Class I
·Ongoing·SleepNet Corporation·April 10, 2024
Spectrum IQ Infusion Pump, Product Code 3570009
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·September 3, 2025
Spectrum IQ Infusion pump, Product Code 357009
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·May 22, 2024
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·June 18, 2025
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·May 15, 2024
Novum IQ Syringe infusion system, Product Code 40800BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·November 15, 2023
iQ Waste Well Adapter, Part Number: 700-3393
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·January 31, 2024
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·February 9, 2022
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·May 28, 2025
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
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 10, 2025
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·September 10, 2025