FDA applicant

Atl Ultrasound, Inc.

Bothell, WA2 decisions2000–20000 recalls

FDA records 2 decisions for Atl Ultrasound, Inc. (Bothell, WA) in 2000: 2 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 2 predicates, 0 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Atl Ultrasound, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Atl Ultrasound, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?