Medical device makerLabelled 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 13, 2026, FDA's public records list 3D-Side with 4 510(k) clearances and 2 AI-enabled devices. The most recent is a 510(k) clearance dated May 12, 2025: Archer PSI 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 |
|---|---|---|
| May 12, 2025 | Archer PSI SystemK243509 · QHE | 510(k) clearances |
| Aug 3, 2022 | CustomizeK221432 · QIH | 510(k) clearances |
| Aug 3, 2022 | CustomizeK221432 · Radiology | AI-enabled devices |
| Mar 16, 2022 | CustomizeK213779 · QIH | 510(k) clearances |
| Mar 16, 2022 | CustomizeK213779 · Radiology | AI-enabled devices |
| Nov 29, 2021 | 3D-CutK212237 · PBF | 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
