Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Merit MedicalLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biosphere Medical with 17 510(k) clearances. The most recent is a 510(k) clearance dated May 16, 2025: Embosphere Microspheres.
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 16, 2025 | Embosphere MicrospheresK250971 · KRD | 510(k) clearances |
| Nov 21, 2019 | Torpedo Gelatin FoamK192480 · KRD | 510(k) clearances |
| Aug 6, 2019 | EmboCube Embolization GelatinK183120 · KRD | 510(k) clearances |
| Jun 18, 2019 | Torpedo Gelatin FoamK183578 · KRD | 510(k) clearances |
| Sep 27, 2018 | EmboCube Embolization GelatinK181021 · KRD | 510(k) clearances |
| Jul 16, 2018 | Embosphere MicrospheresK181300 · KRD | 510(k) clearances |
| Sep 6, 2017 | QuadraSphere MicrospheresK172372 · KRD | 510(k) clearances |
| Jun 21, 2017 | Embosphere MicrospheresDEN160040 · NOY | 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
