Medical device makerLabelled 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 Biogennix with 9 510(k) clearances. The most recent is a 510(k) clearance dated Apr 30, 2024: Morpheus® Moldable; Agilon® Moldable.
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.
| Apr 30, 2024 | Morpheus® Moldable; Agilon® MoldableK240621 · MQV | 510(k) clearances |
| Mar 30, 2020 | Agilon StripK193487 · MQV | 510(k) clearances |
| Feb 13, 2020 | Agilon MoldableK193168 · MQV | 510(k) clearances |
| Aug 9, 2019 | Morpheus-CK190371 · MQV | 510(k) clearances |
| Sep 18, 2018 | Sypher Spacer SystemK181337 · MAX | 510(k) clearances |
| Feb 19, 2015 | SYPHER SPACER SYSTEMK141798 · OVD | 510(k) clearances |
| Jan 15, 2015 | osteoSPAN MorpheusK142828 · MQV | 510(k) clearances |
| May 20, 2014 | OSTEOSPAN MORPHEUSK132377 · MQV | 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
