FDA applicant

Denver Biomaterials, Inc.

Evergreen, CO4 decisions1996–19980 recalls

FDA records 4 decisions for Denver Biomaterials, Inc. (Evergreen, CO) from 1996 to 1998: 4 510(k) clearances. Most are in product codes KPM (Shunt, Peritoneal) and KDD (Kit, Surgical Instrument, Disposable). Its devices cite 4 predicates, 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

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 Biomedical, Inc. 5 Denver Splint Co. 4

Denver Biomaterials, 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?

Other applicant names beginning “Denver”