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 Gateway Alloys with 31 510(k) clearances. The most recent is a 510(k) clearance dated Aug 27, 2001: GPW-SF.
| Aug 27, 2001 | GPW-SFK011659 · EJT | 510(k) clearances |
| Aug 27, 2001 | CONCORD 88K011661 · EJT | 510(k) clearances |
| Jul 16, 2001 | CONCORD 72K011626 · EJT | 510(k) clearances |
| Jul 16, 2001 | CONCORD 82K011628 · EJT | 510(k) clearances |
| Jan 13, 1997 | AURORA 53K964949 · EJT | 510(k) clearances |
| Jan 13, 1997 | LA PLATA 28 (PM-28)K964950 · EJT | 510(k) clearances |
| Jan 13, 1997 | EL DORADO 40K964941 · EJT | 510(k) clearances |
| Jan 13, 1997 | AURORA 52 (PM-01)K964948 · EJT | 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
