Medical device makerLabelled 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 15, 2026, FDA's public records list Bionova Medical, Inc. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Oct 31, 2024: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo.
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.
| Oct 31, 2024 | Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloK243181 · FRO | 510(k) clearances |
| Aug 21, 2024 | Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoK240298 · FRO | 510(k) clearances |
| Nov 13, 2023 | Foundation Dermal Regeneration Scaffold (DRS) SoloK231937 · KGN | 510(k) clearances |
| Aug 11, 2022 | Foundation Dermal Regeneration Scaffold (DRS) SoloK210949 · KGN | 510(k) clearances |
| Apr 5, 2013 | SENTREX BIOSPONGE MPDK123961 · KGN | 510(k) clearances |
| Jun 5, 2012 | HEALEX BIOSPONGE WOUND DRESSINGK112191 · KGN | 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
