BEUDAMED
    19 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I ×

    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

    Spectrum IQ Infusion System with Dose IQ Safety Software

    FDA Enforcement
    Class I ·Terminated·Baxter Healthcare Corporation·October 28, 2020

    Dose IQ Safety Software used with Spectrum IQ Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Baxter Healthcare Corporation·August 18, 2021

    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 12, 2025

    The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·July 19, 2023

    All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

    FDA Enforcement
    Class I ·Terminated·Lifescan Inc·April 24, 2013

    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, Ltd.·December 2, 2015

    Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.

    FDA Enforcement
    Class I ·Terminated·Baxter Healthcare Corporation·August 18, 2021

    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

    iQ 2 Nasal Vented Mask

    FDA Enforcement
    Class I ·Ongoing·SleepNet Corporation·April 10, 2024

    Novum IQ Syringe infusion system, Product Code 40800BAXUS

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·November 15, 2023

    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

    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

    Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·August 20, 2025

    Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·September 10, 2025

    ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.

    FDA Enforcement
    Class I ·Terminated·Alcon Research, Ltd.·August 19, 2015

    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·May 15, 2024