3 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
FDA Enforcement
Class II
·Terminated·Boddingtons Plastics Ltd·April 22, 2020
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
FDA Enforcement
Class II
·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
FDA Enforcement
Class II
·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025