FDA applicant

Omnis Surgical, Inc.

Deerfield, IL4 decisions1985–19850 recalls

FDA records 4 decisions for Omnis Surgical, Inc. (Deerfield, IL) in 1985: 4 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and FCG (Biopsy Needle). 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 Omnis Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omnis Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Omnis Surgical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?