FDA applicant

Denver Splint Co.

Englewood, CO4 decisions1993–19940 recalls

FDA records 4 decisions for Denver Splint Co. (Englewood, CO) from 1993 to 1994: 4 510(k) clearances. Most are in product codes EMX (Balloon, Epistaxis) and GEI (Electrosurgical, Cutting & Coagulation &…). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Denver Splint Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Denver Splint Co.’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 Biomedical, Inc. 5 Denver Biomaterials, Inc. 4

Denver Splint Co.

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”