FDA applicant

Colorado Therapeutics, LLC

Broomfield, CO2 decisions2016–20170 recalls

FDA records 2 decisions for Colorado Therapeutics, LLC (Broomfield, CO) from 2016 to 2017: 2 510(k) clearances. All are in product code FTM (Mesh, Surgical). Its devices cite 3 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, general and plastic surgery panel, where it files most

How often FDA has decided Colorado Therapeutics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Colorado Therapeutics, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Colorado”

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

Colorado Medical, Inc. 6 Colorado Medtech, Inc. 2 Colorado Catheter Company, Inc. 1 Colorado Hearing Systems, Inc. 1 Colorado Biomedical, Inc. 1

Colorado Therapeutics, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Colorado”