5 results
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41ms
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Sources: EU EUDAMED, US FDA
IANTREK INC.
FDA registration
IANTREK INC.·3 products·🇺🇸 United States
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 Recall
Open, Classified
·Iantrek Inc.·Product code HMZ·September 6, 2025
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 Recall
Open, Classified
·Iantrek Inc.·Product code HMX·September 6, 2025
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