FDA applicant

Endomedix

Irvine, CA7 decisions1992–19940 recalls

FDA records 7 decisions for Endomedix (Irvine, CA) from 1992 to 1994: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FET (Endoscopic Video Imaging System/Component…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Endomedix since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Endomedix

Which product codes does it file in?

What has FDA decided for it lately?