FDA applicant

Entlab OY

Richmond, CA1 decision1996–19960 recalls

FDA records 1 decision for Entlab OY (Richmond, CA) in 1996: 1 510(k) clearance. All are in product code LWI (Ultrasound, Sinus). 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 Entlab OY’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Entlab OY since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Entlab OY

Which product codes does it file in?

What has FDA decided for it lately?