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

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

10 devices

1-10 of 10

Cleared Jan 16, 2026

Cardiovascular · 260d

Cleared Feb 12, 2025

Cardiovascular · 268d

Cleared May 24, 2024

Cardiovascular · 57d

Cleared Sep 14, 2022

Cardiovascular · 278d

Cleared Nov 24, 2020

Cardiovascular · 55d

Cleared Jun 18, 2020

Cardiovascular · 175d

Cleared Jan 02, 2020

Cardiovascular · 170d

Cleared Dec 12, 2019

Cardiovascular · 106d

Cleared Sep 13, 2016

Cardiovascular · 131d

Cleared Jun 12, 2015

Opto Wire and OptoMonitor System

Cardiovascular · 270d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 27, 2026