FDA applicant

Abeon Medical Corporation

Brecksville, OH2 decisions2014–20140 recalls

FDA records 2 decisions for Abeon Medical Corporation (Brecksville, OH) in 2014: 2 510(k) clearances. All are in product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 1 predicate, 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, anesthesiology panel, where it files most

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

FDA decisions per year

2in 2014

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Abeon Medical Corporation by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Abeon Medical Corporation

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?