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 15, 2026, FDA's public records list Applied Medical with 14 510(k) clearances. The most recent is a 510(k) clearance dated Dec 16, 2021: Voyant Fine Fusion Device (EB230).
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.
| Dec 16, 2021 | Voyant Fine Fusion Device (EB230)K202818 · GEI | 510(k) clearances |
| Apr 29, 2020 | GelPOINT Mini Advanced Access PlatformK191866 · GCJ | 510(k) clearances |
| Oct 2, 2012 | EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SETK122619 · BTA | 510(k) clearances |
| Oct 23, 2007 | EXPANDING VASCULAR SHEATHK070865 · DYB | 510(k) clearances |
| Feb 1, 2001 | SUCTION IRRIGATORK003443 · FHF | 510(k) clearances |
| Jan 8, 2001 | FLEXIBLE OCCLUSION SYSTEMK002915 · DXC | 510(k) clearances |
| Jun 2, 1992 | BIO-POLAR FORCEPSK915826 · GEI | 510(k) clearances |
| Apr 22, 1991 | SURGICAL TROCARK911462 · DRC | 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
