Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 Systems and its 2 subsidiaries with 21 510(k) clearances and 1 AI-enabled device. The most recent is a 510(k) clearance dated Jun 3, 2026: VSP System (Titanium Palatal Splint).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, 3D Systems and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 3, 2026 | VSP System (Titanium Palatal Splint)K261826 · DZJ | 510(k) clearances |
| Dec 5, 2025 | VSP Orthopedics SystemK250711 · PBF | 510(k) clearances |
| Oct 25, 2024 | Salto Talaris Ankle PSI SystemK243173 · OYK | 510(k) clearances |
| Oct 25, 2024 | Cadence Ankle PSI SystemK243174 · OYK | 510(k) clearances |
| Aug 30, 2024 | Cadence Ankle PSI SystemK241326 · OYK | 510(k) clearances |
| Aug 30, 2024 | Salto Talaris Ankle PSI SystemK241148 · OYK | 510(k) clearances |
| Apr 4, 2024 | VSP PEEK Cranial ImplantK231834 · GWO | 510(k) clearances |
| Jun 30, 2023 | Vantage PSI SystemK231585 · OYK | 510(k) clearances |
| Aug 29, 2019 | D2PK183489 · Radiology | 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
