FDA applicant

Hyox Systems, Ltd.

Washington, DC1 decision1999–19990 recalls

FDA records 1 decision for Hyox Systems, Ltd. (Washington, DC) in 1999: 1 510(k) clearance. All are in product code CBF (Chamber, Hyperbaric). 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 Hyox Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hyox Systems, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Hyox”

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

Hyox Systems C/O Mechidyne Systems, Inc. 1

Hyox Systems, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hyox”