FDA applicant

Artann Laboratories, Inc.

Washington D.C., DC1 decision2012–20120 recalls

FDA records 1 decision for Artann Laboratories, Inc. (Washington D.C., DC) in 2012: 1 De Novo grant. All are in product code OQT (Prostate Lesion, Documentation, 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Artann Laboratories, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Artann Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?