Medical device makerLabelled 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 13, 2026, FDA's public records list Disior with 6 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Feb 26, 2026: ENOS Software Guided External Fixation System.
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.
| Date | Record | Source |
|---|---|---|
| Feb 26, 2026 | ENOS Software Guided External Fixation SystemK253764 · OSN | 510(k) clearances |
| Sep 29, 2025 | SMART PCFDK250023 · QIH | 510(k) clearances |
| Sep 29, 2025 | SMART PCFDK250023 · Radiology | AI-enabled devices |
| Jul 2, 2024 | SMART Bun-Yo-Matic X-RayK240736 · QIH | 510(k) clearances |
| Jul 2, 2024 | SMART Bun-Yo-Matic X-RayK240736 · Radiology | AI-enabled devices |
| Jun 20, 2024 | SMART Bun-Yo-Matic CTK240642 · QIH | 510(k) clearances |
| Jun 20, 2024 | SMART Bun-Yo-Matic CTK240642 · Radiology | AI-enabled devices |
| Dec 8, 2023 | BonelogicK223757 · QIH | 510(k) clearances |
| Dec 8, 2023 | BonelogicK223757 · Radiology | AI-enabled devices |
| Feb 5, 2021 | BonelogicK203290 · 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
