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 Kaneka CorporationLabelled 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 Kaneka Pharma America with 4 510(k) clearances. The most recent is a 510(k) clearance dated Apr 25, 2020: i-ED COIL.
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.
| Apr 25, 2020 | i-ED COILK192068 · HCG | 510(k) clearances |
| Apr 18, 2017 | Lacriflow CLK170247 · OKS | 510(k) clearances |
| Jul 30, 2012 | XPRESSWAY RX CATHETER (6F LD-VERISON)K121301 · QEZ | 510(k) clearances |
| Oct 22, 2010 | KANEKA PHARMA AMERICA XPRESS-WAY RXK101839 · QEZ | 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
