Medical Device Manufacturer · CA , Quebec

Opsens, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2015

Recent clearances: OptoMonitor 3, OptoMonitor 3, PacePro Wire

10
Total
10
Cleared
0
Denied

Opsens, Inc. has 10 FDA 510(k) cleared cardiovascular devices. Based in Quebec, CA.

Latest FDA clearance: Jan 2026. Active since 2015.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Ultra Life Science Solutions, Inc. and Ultra Lifescience, Inc..

FDA 510(k) Regulatory Record - Opsens, Inc.

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