FDA applicant

Bioflex, Inc.

Columbus, OH1 decision1995–19954 recalls

FDA records 1 decision for Bioflex, Inc. (Columbus, OH) in 1995: 1 510(k) clearance. All are in product code GXY (Electrode, Cutaneous). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Bioflex, Inc. since 2007.

Recalls per year

4in 2011

2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Bioflex, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?