6 results
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7ms
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Sources: EU EUDAMED, US FDA
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
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¿ Verio IQ 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¿ Verio IQ 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
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