FDA applicant

Cea America Corp.

Mchenry, IL5 decisions1984–19960 recalls

FDA records 5 decisions for Cea America Corp. (Mchenry, IL) from 1984 to 1996: 5 510(k) clearances. Most are in product codes IWZ (Film, Radiographic) and GKZ (Counter, Differential Cell). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Cea America Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cea America Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cea America Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Cea America Corp.

Which product codes does it file in?

What has FDA decided for it lately?