FDA applicant

Hedeco

Mchenry, IL4 decisions1981–19830 recalls

FDA records 4 decisions for Hedeco (Mchenry, IL) from 1981 to 1983: 4 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and JWZ (Kit, Screening, Trichomonas). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Hedeco since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hedeco

Which product codes does it file in?

What has FDA decided for it lately?