Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SpainLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Adas3D Medical with 5 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Jun 29, 2026: ADAS 3D.
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.
| Jun 29, 2026 | ADAS 3DK253969 · QIH | 510(k) clearances |
| Jun 29, 2026 | ADAS 3DK253969 · Radiology | AI-enabled devices |
| Sep 9, 2024 | ADAS 3DK240791 · QIH | 510(k) clearances |
| Sep 9, 2024 | ADAS 3DK240791 · Radiology | AI-enabled devices |
| May 23, 2023 | ADAS 3DK230803 · LLZ | 510(k) clearances |
| Sep 3, 2021 | ADAS 3DK212421 · LLZ | 510(k) clearances |
| Apr 5, 2021 | ADAS 3DK210850 · LLZ | 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
