FDA applicant

Del Medical, Inc.

Bloomingdale, IL4 decisions2014–20230 recalls

FDA records 4 decisions for Del Medical, Inc. (Bloomingdale, IL) from 2014 to 2023: 4 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and IZL (System, X-Ray, Mobile). Its devices cite 4 predicates, 1 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 Del Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Del Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Del Medical, 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?