Biotech companyLabelled 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 14, 2026, FDA's public records list Organogenesis with 12 510(k) clearances. The most recent is a 510(k) clearance dated May 2, 2023: FortiShield (Biosynthetic Wound Matrix).
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.
| May 2, 2023 | FortiShield (Biosynthetic Wound Matrix)K212579 · KGN | 510(k) clearances |
| Jul 1, 2022 | PuraPly Micronized Wound Matrix (PuraPly MZ)K220317 · KGN | 510(k) clearances |
| Aug 30, 2007 | FORTAGEN ORAL MEMBRANEK071555 · NPL | 510(k) clearances |
| Nov 8, 2005 | FORTADERM ANTIMICROBIAL WOUND DRESSINGK051647 · FRO | 510(k) clearances |
| Nov 2, 2004 | CUFFPATCHK042809 · FTM | 510(k) clearances |
| May 15, 2002 | FORTAFLEX SURGICAL SLINGK021107 · FTM | 510(k) clearances |
| May 10, 2002 | FORTAFLEX SURGICAL MESHK021105 · FTM | 510(k) clearances |
| Mar 18, 2002 | FORTAFLEX SURGICAL MESHK020049 · FTM | 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
