Opsens, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251367OptoMonitor 3January 16, 2026
K241418OptoMonitor 3February 12, 2025
K240864PacePro WireMay 24, 2024
K213854SavvyWireSeptember 14, 2022
K202943OptoMonitor 3November 24, 2020
K193620OptoMonitor 3June 18, 2020
K191907OptoWire IIIJanuary 2, 2020
K192340OptoMonitorDecember 12, 2019
K161263OptoMonitor IISeptember 13, 2016
K152991OptoWire DeuxFebruary 11, 2016
K142598Opto Wire and OptoMonitor SystemJune 12, 2015