FDA applicant

Navion Biomedical Corp.

Stoughton, MA5 decisions1990–19990 recalls

FDA records 5 decisions for Navion Biomedical Corp. (Stoughton, MA) from 1990 to 1999: 5 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 3 predicates, 1 of them its own earlier devices. 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Navion Biomedical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Navion Biomedical Corp.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?