FDA applicant

Atlantis Diagnostics Intl., Inc.

Bothell, WA3 decisions1995–19980 recalls

FDA records 3 decisions for Atlantis Diagnostics Intl., Inc. (Bothell, WA) from 1995 to 1998: 3 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). 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 Atlantis Diagnostics Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Atlantis Diagnostics Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Atlantis”

FDA records each applicant name separately; these may or may not be the same firm.

Atlantis Components, Inc. 18 Atlantis Scientific Corp. 1 Atlantis Luminescent Products, LLC 1

Atlantis Diagnostics Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Atlantis”