FDA applicant

Imagyn Medical Technologies, Inc.

Laguna Niguel, CA7 decisions1998–20030 recalls

FDA records 7 decisions for Imagyn Medical Technologies, Inc. (Laguna Niguel, CA) from 1998 to 2003: 7 510(k) clearances. Most are in product codes LKY (Device, External Penile Rigidity) and DQA (Oximeter). Its devices cite 14 predicates, 0 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Imagyn Medical Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Imagyn”

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

Imagyn Medical, Inc. 19 Imagyn Surgical 3

Imagyn Medical Technologies, 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?

Other applicant names beginning “Imagyn”