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 its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Hydrofera, LLC with 7 510(k) clearances. The most recent is a 510(k) clearance dated Nov 6, 2019: Hydrofera Blue READY - Border.
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.
| Date | Record | Source |
|---|---|---|
| Nov 6, 2019 | Hydrofera Blue READY - BorderK190268 · FRO | 510(k) clearances |
| Jan 2, 2014 | HYDROFERA BLUE PU BACTERIOSTATIC DRESSINGK130670 · FRO | 510(k) clearances |
| Jan 17, 2003 | HYDROFERA BACTERIOSTATIC WOUND DRESSINGK023138 · FRO | 510(k) clearances |
| Jan 11, 2002 | HYDROFERA BACTERIOSTATIC WOUND DRESSINGK013462 · FRO | 510(k) clearances |
| Sep 14, 1999 | HYDROFERA BACTERISTATIC NASAL DRESSINGK983276 · EMX | 510(k) clearances |
| Mar 2, 1998 | HYDROFERA SURGICAL SPEARK974313 · HOZ | 510(k) clearances |
| Feb 13, 1998 | HYDROFERA FEMORAL WICKK974316 · EFQ | 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
