FDA applicant

Leisegang Medical, Inc.

Boca Raton, FL10 decisions1986–19990 recalls

FDA records 10 decisions for Leisegang Medical, Inc. (Boca Raton, FL) from 1986 to 1999: 10 510(k) clearances. Most are in product codes HEX (Colposcope (And Colpomicroscope)) and HIF (Insufflator, Laparoscopic). Its devices cite 2 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Leisegang Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Leisegang Medical, 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?