38 results
·
13ms
·
Sources: EU EUDAMED, US FDA
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
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·October 28, 2020
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·October 24, 2018
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
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
GE Healthcare Discovery IQ X-ray system
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 21, 2017
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·August 8, 2018
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
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
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
FDA Enforcement
Class II
·Terminated·Butterfly Network, Inc.·April 8, 2020
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 5, 2021
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012
"***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
FDA Enforcement
Class II
·Terminated·Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.·November 14, 2012