3 results
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6ms
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Sources: EU EUDAMED, US FDA
Pentax Medical Video Processor; Model Number: EPK-i8020c;
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·August 27, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
FDA Enforcement
Class II
·Ongoing·Pentax of America Inc·March 5, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025