FDA applicant

Safersonic Us, Inc.

Highland Park, IL1 decision2019–20190 recalls

FDA records 1 decision for Safersonic Us, Inc. (Highland Park, IL) in 2019: 1 510(k) clearance. All are in product code MUI (Media, Coupling, Ultrasound). 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 Safersonic Us, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Safersonic Us, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Safersonic”

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

Safersonic Medizinprodukte GmbH 1

Safersonic Us, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Safersonic”