Company ยท CA
Opsens, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2026 | K251367 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| Feb 12, 2025 | K241418 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| May 24, 2024 | K240864 | PacePro Wire Opsens, Inc., CA | DQX |
| Sep 14, 2022 | K213854 | SavvyWire Opsens, Inc., CA | DQX |
| Nov 24, 2020 | K202943 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| Jun 18, 2020 | K193620 | OptoMonitor 3 Opsens, Inc., CA | DXO |
| Jan 2, 2020 | K191907 | OptoWire III Opsens, Inc., CA | DQX |
| Dec 12, 2019 | K192340 | OptoMonitor Opsens, Inc., CA | DXO |
| Sep 13, 2016 | K161263 | OptoMonitor II Opsens, Inc., CA | DXO |
| Feb 11, 2016 | K152991 | OptoWire Deux Opsens, CA | DQX |
| Jun 12, 2015 | K142598 | Opto Wire and OptoMonitor System Opsens, Inc., CA | DQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||