Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-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 Oxehealth Limited with 6 AI-enabled devices and 5 510(k) clearances. The most recent is a 510(k) clearance dated Feb 2, 2026: Vital Signs.
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.
| Feb 2, 2026 | Vital SignsK251200 · QME | 510(k) clearances |
| Feb 2, 2026 | Vital SignsK251200 · Cardiovascular | AI-enabled devices |
| Aug 27, 2025 | Vital SignsK243687 · QME | 510(k) clearances |
| Aug 27, 2025 | Vital SignsK243687 · Cardiovascular | AI-enabled devices |
| Apr 3, 2024 | Oxevision Sleep DeviceK233618 · LEL | 510(k) clearances |
| Apr 3, 2024 | Oxevision Sleep DeviceK233618 · Neurology | AI-enabled devices |
| Apr 29, 2022 | Oxehealth Vital SignsK220899 · QME | 510(k) clearances |
| Apr 29, 2022 | Oxehealth Vital SignsK220899 · Cardiovascular | AI-enabled devices |
| Jul 20, 2021 | Vital SignsK211906 · QME | 510(k) clearances |
| Jul 20, 2021 | Vital SignsK211906 · Cardiovascular | AI-enabled devices |
| Mar 26, 2021 | Oxehealth Vital SignsDEN200019 · QME | 510(k) clearances |
| Mar 26, 2021 | Oxehealth Vital SignsDEN200019 · Cardiovascular | AI-enabled devices |
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
