FDA applicant

Mie America, Inc.

Elk Grove Village, IL1 decision2006–20060 recalls

FDA records 1 decision for Mie America, Inc. (Elk Grove Village, IL) in 2006: 1 510(k) clearance. All are in product code KPS (System, Tomography, Computed, Emission). 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 Mie America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mie America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Mie America, Inc.

Which product codes does it file in?

What has FDA decided for it lately?