FDA applicant

Colorado Medtech, Inc.

Boulder, CO2 decisions1997–19990 recalls

FDA records 2 decisions for Colorado Medtech, Inc. (Boulder, CO) from 1997 to 1999: 2 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and CAW (Generator, Oxygen, Portable). 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 Colorado Medtech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Colorado Medtech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Colorado Medtech, Inc. by year, 2007–2026Sources: 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 Therapeutics, LLC 2 Colorado Catheter Company, Inc. 1 Colorado Hearing Systems, Inc. 1 Colorado Biomedical, Inc. 1

Colorado Medtech, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Colorado”