FDA applicant

Denver Biomedical, Inc.

Golden, CO5 decisions2001–20050 recalls

FDA records 5 decisions for Denver Biomedical, Inc. (Golden, CO) from 2001 to 2005: 5 510(k) clearances. Most are in product codes KPM (Shunt, Peritoneal) and DWM (Apparatus, Suction, Patient Care). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Denver Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Denver Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Denver”

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

Denver Biomedicals, Inc. 10 Denver Biomaterials, Inc. 4 Denver Splint Co. 4

Denver Biomedical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Denver”