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 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Nanofiber Solutions with 7 510(k) clearances. The most recent is a 510(k) clearance dated Feb 27, 2025: Rotium.
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.
| Feb 27, 2025 | RotiumK250021 · OWW | 510(k) clearances |
| Jul 29, 2024 | BIOCHARGEK241912 · MAI | 510(k) clearances |
| Jul 5, 2023 | Rotium Bioresorbable WickK231641 · MAI | 510(k) clearances |
| Jun 25, 2020 | Rotium Bioresorbable WickK201414 · MAI | 510(k) clearances |
| Mar 11, 2019 | Rotium Bioresorbable WickK183236 · MAI | 510(k) clearances |
| Mar 2, 2018 | Phoenix Wound MatrixK173544 · QSZ | 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
