FDA applicant

Zeon Medical Corp.

White Plains, NY3 decisions1991–19910 recalls

FDA records 3 decisions for Zeon Medical Corp. (White Plains, NY) in 1991: 3 510(k) clearances. Most are in product codes LDF (Electrode, Pacemaker, Temporary) and BSS (Tube, Nasogastric). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Zeon Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Zeon Medical Corp.

Which product codes does it file in?

What has FDA decided for it lately?