Medical Device Manufacturer · CA , Quebec

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

10 submissions · 10 cleared · Since 2015
10
Total
10
Cleared
0
Denied

FDA 510(k) cleared devices by Opsens, Inc. Cardiovascular ✕

10 devices
1-10 of 10
Cleared Jan 16, 2026
OptoMonitor 3
K251367 · DXO
Cardiovascular · 260d
Cleared Feb 12, 2025
OptoMonitor 3
K241418 · DXO
Cardiovascular · 268d
Cleared May 24, 2024
PacePro Wire
K240864 · DQX
Cardiovascular · 57d
Cleared Sep 14, 2022
SavvyWire
K213854 · DQX
Cardiovascular · 278d
Cleared Nov 24, 2020
OptoMonitor 3
K202943 · DXO
Cardiovascular · 55d
Cleared Jun 18, 2020
OptoMonitor 3
K193620 · DXO
Cardiovascular · 175d
Cleared Jan 02, 2020
OptoWire III
K191907 · DQX
Cardiovascular · 170d
Cleared Dec 12, 2019
OptoMonitor
K192340 · DXO
Cardiovascular · 106d
Cleared Sep 13, 2016
OptoMonitor II
K161263 · DXO
Cardiovascular · 131d
Cleared Jun 12, 2015
Opto Wire and OptoMonitor System
K142598 · DQX
Cardiovascular · 270d
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