Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Opsens, Inc.

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories2
Latest Approval2026-01-16
TypeNumberDevice NameCodeDate
510(k) K251367 OptoMonitor 3 DXO 2026-01-16 View
510(k) K241418 OptoMonitor 3 DXO 2025-02-12 View
510(k) K240864 PacePro Wire DQX 2024-05-24 View
510(k) K213854 SavvyWire DQX 2022-09-14 View
510(k) K202943 OptoMonitor 3 DXO 2020-11-24 View
510(k) K193620 OptoMonitor 3 DXO 2020-06-18 View
510(k) K191907 OptoWire III DQX 2020-01-02 View
510(k) K192340 OptoMonitor DXO 2019-12-12 View
510(k) K161263 OptoMonitor II DXO 2016-09-13 View
↑