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 Cea America Corp. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jun 5, 1996: MEDICOUNT DEKA HEMATOLOGY ANALYZER.
| Jun 5, 1996 | MEDICOUNT DEKA HEMATOLOGY ANALYZERK942525 · GKZ | 510(k) clearances |
| Mar 5, 1984 | WILCOR-XR RP MEDICAL FILMK834613 · IWZ | 510(k) clearances |
| Mar 5, 1984 | WILCOR-XR RP-L MEDICAL FILMK834614 · IWZ | 510(k) clearances |
| Feb 27, 1984 | WILCOR-XR RP-OG MEDICAL FILMK834612 · IWZ | 510(k) clearances |
| Feb 21, 1984 | SINGUL-XR RP NON SCREEN MED. FILMK834611 · IWZ | 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
