Opsens, Inc. - FDA 510(k) Cleared Devices
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.
FDA 510(k) cleared devices by Opsens, Inc.
10 devices
Cleared
Jan 16, 2026
OptoMonitor 3
Cardiovascular
260d
Cleared
Feb 12, 2025
OptoMonitor 3
Cardiovascular
268d
Cleared
May 24, 2024
PacePro Wire
Cardiovascular
57d
Cleared
Sep 14, 2022
SavvyWire
Cardiovascular
278d
Cleared
Nov 24, 2020
OptoMonitor 3
Cardiovascular
55d
Cleared
Jun 18, 2020
OptoMonitor 3
Cardiovascular
175d
Cleared
Jan 02, 2020
OptoWire III
Cardiovascular
170d
Cleared
Dec 12, 2019
OptoMonitor
Cardiovascular
106d
Cleared
Sep 13, 2016
OptoMonitor II
Cardiovascular
131d
Cleared
Jun 12, 2015
Opto Wire and OptoMonitor System
Cardiovascular
270d