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., part of NovartisLabelled 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. See the Novartis group view.
As of Nov 14, 2026, FDA's public records list Wesley Jessen with 11 510(k) clearances. The most recent is a 510(k) clearance dated Mar 20, 2000: PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS.
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
