6 results
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15ms
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Sources: EU EUDAMED, US FDA
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
Intera 1.5T, Magnetic Resonance System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 24, 2024
Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·July 16, 2025
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·August 28, 2024
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023