FDA applicant

Ultrasound Medical Devices, Inc.

Ann Arbor, MI2 decisions2010–20110 recalls

FDA records 2 decisions for Ultrasound Medical Devices, Inc. (Ann Arbor, MI) from 2010 to 2011: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 3 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 Ultrasound Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Ultrasound Medical Devices, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ultrasound Medical Devices, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Ultrasound”

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

Ultrasound Biotechnology (Shanghai) Co., Ltd. 1 Ultrasound AI 1

Ultrasound Medical Devices, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Ultrasound”