FDA applicant

Copioumed Intl., Inc.

Green Valley, AZ8 decisions1996–20030 recalls

FDA records 8 decisions for Copioumed Intl., Inc. (Green Valley, AZ) from 1996 to 2003: 8 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and FXP (Cover, Shoe, Operating-Room). Its devices cite 5 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Copioumed Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Copioumed Intl., Inc.’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 “Copioumed”

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

Copioumed International, Inc. 2

Copioumed Intl., Inc.

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 “Copioumed”