FDA applicant

Amco International Manufacturing & Design, Inc.

Elizabeth, CO5 decisions2007–20090 recalls

FDA records 5 decisions for Amco International Manufacturing & Design, Inc. (Elizabeth, CO) from 2007 to 2009: 5 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 13 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, cardiovascular panel, where it files most

How often FDA has decided Amco International Manufacturing & Design, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 3 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amco International Manufacturing & Design, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Amco International Manufacturing & Design, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?