2 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.
FDA Enforcement
Class II
·Ongoing·Iantrek Inc.·October 22, 2025
C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.
FDA Enforcement
Class II
·Ongoing·Iantrek Inc.·October 22, 2025