Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of HaemoneticsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Opsens with 11 510(k) clearances. The most recent is a 510(k) clearance dated Jan 16, 2026: OptoMonitor 3.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 16, 2026 | OptoMonitor 3K251367 · DXO | 510(k) clearances |
| Feb 12, 2025 | OptoMonitor 3K241418 · DXO | 510(k) clearances |
| May 24, 2024 | PacePro WireK240864 · DQX | 510(k) clearances |
| Sep 14, 2022 | SavvyWireK213854 · DQX | 510(k) clearances |
| Nov 24, 2020 | OptoMonitor 3K202943 · DXO | 510(k) clearances |
| Jun 18, 2020 | OptoMonitor 3K193620 · DXO | 510(k) clearances |
| Jan 2, 2020 | OptoWire IIIK191907 · DQX | 510(k) clearances |
| Dec 12, 2019 | OptoMonitorK192340 · DXO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
