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 14, 2026, FDA's public records list The Orvis Company with 9 510(k) clearances. The most recent is a 510(k) clearance dated Mar 2, 1995: ORVIS KEY WEST SUNGLASSES.
| Mar 2, 1995 | ORVIS KEY WEST SUNGLASSESK950609 · HQY | 510(k) clearances |
| Aug 4, 1994 | ORVIS DRIVING GLASSESK943161 · HQY | 510(k) clearances |
| Aug 2, 1994 | ORVIS LIGHT WEIGHT POLARIZED CLIP-ONSK942951 · HQY | 510(k) clearances |
| Aug 2, 1994 | ORVIS POLARIZED BI-FOCALSK943131 · HQY | 510(k) clearances |
| Jul 25, 1994 | ORVIS WORLD FINEST POLARIZED CLIP ONSK942952 · HQY | 510(k) clearances |
| Jul 8, 1994 | SUNGLASSESK941910 · HQY | 510(k) clearances |
| Jun 3, 1994 | SUNGLASSESK941751 · HQY | 510(k) clearances |
| Mar 24, 1994 | ORVIS MARQUESAS FISHING GLASSESK940354 · HQY | 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