FDA applicant

Entrogen, Inc.

Woodland Hills1 decision2023–20230 recalls

FDA records 1 decision for Entrogen, Inc. (Woodland Hills) in 2023: 1 original PMA approval. All are in product code OWD (Somatic Gene Mutation Detection System). 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, pathology panel, where it files most

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

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Entrogen, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Entrogen, Inc.

Which product codes does it file in?

What has FDA decided for it lately?