3 results
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14ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.
FDA Enforcement
Class II
·Ongoing·Energetiq Technology Inc·February 5, 2020
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025