FDA applicant

Auxogyn, Inc.

Menlo Park, CA4 decisions2011–20140 recalls

FDA records 4 decisions for Auxogyn, Inc. (Menlo Park, CA) from 2011 to 2014: 3 510(k) clearances and 1 De Novo grant. Most are in product codes MQK (Labware, Assisted Reproduction) and PBH (Embryo Image Assessment System, Assisted…). Its devices cite 3 predicates, 2 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

3in 2014

2011high 3 (2014) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Auxogyn, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Auxogyn, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?