Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Human Xtensions with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jun 5, 2023: HandX™ Self-Righting Needle Holder.
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 5, 2023 | HandX™ Self-Righting Needle HolderK223718 · GCJ | 510(k) clearances |
| May 10, 2023 | HandX™ Monopolar ScissorsK230491 · GCJ | 510(k) clearances |
| Jan 12, 2023 | HandX Instrument - Monopolar SpatulaK222011 · GCJ | 510(k) clearances |
| Sep 13, 2021 | HandXK212214 · GCJ | 510(k) clearances |
| Feb 1, 2021 | Monopolar HookK203603 · GCJ | 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
