FDA applicant

Medigus, Ltd.

Washington D.C., DC4 decisions2012–20150 recalls

FDA records 4 decisions for Medigus, Ltd. (Washington D.C., DC) from 2012 to 2015: 4 510(k) clearances. All are in product code ODE (Endoscopic Suture/Plication System…). Its devices cite 7 predicates, 3 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

2in 2015

2012high 2 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Medigus, Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Medigus, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?