FDA applicant

Integrated Medical Systems, Inc.

Golden, CO5 decisions1987–20080 recalls

FDA records 5 decisions for Integrated Medical Systems, Inc. (Golden, CO) from 1987 to 2008: 5 510(k) clearances. Most are in product codes DXG (Computer, Diagnostic, Pre-Programmed…) and BZG (Spirometer, Diagnostic). Its devices cite 1 predicate, 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, cardiovascular panel, where it files most

How often FDA has decided Integrated Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Integrated Medical Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?