BEUDAMED
    48 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Enforcement
    Class II ·Completed·Materialise USA LLC·August 31, 2022

    IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).

    FDA Enforcement
    Class II ·Terminated·Data Innovations, LLC·October 31, 2018

    GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 22, 2013

    GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 20, 2013

    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·October 24, 2018

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

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 20, 2024

    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

    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

    FDA Enforcement
    Class II ·Terminated·Alcon Research LLC·June 17, 2020

    Spectrum IQ Infusion Pump, Product Code 3570009

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·September 3, 2025

    GE Healthcare Discovery IQ X-ray system

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 21, 2017

    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

    iQ Waste Well Adapter, Part Number: 700-3393

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·January 31, 2024

    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

    iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·May 24, 2023

    Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is capable of being folded prior to insertion. The lens gently unfolds to a fullsize lens body following implantation. The lens has a biconvex optic with supporting haptics The AcrySof IQ IOLs are provided in the ULTRASERT Preloaded Delivery System for a convenient, controlled means to reliably place these lenses into the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·September 7, 2016