Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 2 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Tokuyama Corporation and its 2 subsidiaries with 41 510(k) clearances. The most recent is a 510(k) clearance dated May 25, 2021: Tokuyama Universal Bond II.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Tokuyama Corporation and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 25, 2021 | Tokuyama Universal Bond IIK203760 · KLE | 510(k) clearances |
| Feb 3, 2021 | Omnichroma Flow BulkK203598 · EBF | 510(k) clearances |
| Aug 19, 2020 | Omnichroma FlowK193537 · EBF | 510(k) clearances |
| Oct 4, 2019 | Tokuyama Rebase IIIK190940 · EBI | 510(k) clearances |
| Jul 12, 2018 | Estelite Universal FlowK180613 · EBF | 510(k) clearances |
| Feb 27, 2018 | OMNICHROMAK173275 · EBF | 510(k) clearances |
| Nov 28, 2017 | TOKUYAMA UNIVERSAL BONDK171226 · KLE | 510(k) clearances |
| Jul 5, 2017 | TOKUYAMA CUREGRACEK170549 · EBI | 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