Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled 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 15, 2026, FDA's public records list Winner Medical and its 1 subsidiaries with 20 510(k) clearances. The most recent is a 510(k) clearance dated Oct 10, 2025: Collagen Wound Dressing.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Winner Medical and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 10, 2025 | Collagen Wound DressingK252001 · KGN | 510(k) clearances |
| Jun 18, 2025 | Procedure mask/Surgical mask/Face maskK250082 · FXX | 510(k) clearances |
| Dec 1, 2023 | Antibacterial Gel Wound DressingK231057 · FRO | 510(k) clearances |
| Nov 10, 2023 | Skin and Wound CleanserK231564 · FRO | 510(k) clearances |
| Oct 12, 2023 | Collagen Wound DressingK231152 · KGN | 510(k) clearances |
| Jun 21, 2023 | Antibacterial BandageK221311 · FRO | 510(k) clearances |
| Mar 6, 2023 | Procedure mask/Surgical mask/Face maskK223232 · FXX | 510(k) clearances |
| Jan 30, 2023 | PHMB Wound DressingK221532 · FRO | 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
