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 Hironic with 9 510(k) clearances. The most recent is a 510(k) clearance dated Aug 31, 2026: SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003).
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.
| Aug 31, 2026 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)K260387 · NFO | 510(k) clearances |
| Apr 6, 2026 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)K260397 · GEI | 510(k) clearances |
| Sep 29, 2025 | NEW DOUBLO 2.0K251334 · GEI | 510(k) clearances |
| Nov 8, 2024 | Plasonic (Plasonic)K241099 · GEI | 510(k) clearances |
| Jun 24, 2024 | SILKROK233123 · GEI | 510(k) clearances |
| Jun 3, 2022 | SILKROK210084 · GEI | 510(k) clearances |
| Oct 19, 2021 | PICOHIK201773 · GEX | 510(k) clearances |
| Dec 1, 2020 | SLIMUSK192970 · PKT | 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
