FDA applicant

Ivex Medical, Inc.

Englewood, CO3 decisions1988–19900 recalls

FDA records 3 decisions for Ivex Medical, Inc. (Englewood, CO) from 1988 to 1990: 3 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and HGX (Pump, Breast, Powered). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Ivex Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Ivex Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?