Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled 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 13, 2026, FDA's public records list Gunze Limited and its 1 subsidiaries with 37 510(k) clearances. The most recent is a 510(k) clearance dated Aug 26, 2022: NEOVEIL Staple Line Reinforcement.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Gunze Limited and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 26, 2022 | NEOVEIL Staple Line ReinforcementK221487 · OXC | 510(k) clearances |
| Jul 14, 2022 | PELNAC Meshed Bilayer Wound MatrixK213498 · KGN | 510(k) clearances |
| Feb 9, 2022 | PELNAC Wound MatrixK213573 · KGN | 510(k) clearances |
| Apr 29, 2020 | PELNAC Bilayer Wound MatrixK191992 · KGN | 510(k) clearances |
| May 9, 2018 | DSM Biomedical Calcium Phosphate Cement with MicrospheresK173572 · MQV | 510(k) clearances |
| Apr 3, 2018 | DSM Biomedical Calcium Phosphate CementK173362 · MQV | 510(k) clearances |
| May 16, 2017 | DSM Biomedical Dental Bone GraftK170245 · NPM | 510(k) clearances |
| Jun 7, 2016 | DSM Biomedical Porcine Pericardium Dental MembraneK160474 · NPL | 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
