510(k) Report

FDA applicant

Med-Genesis, Inc.

Great Neck,, NY1 decision1994–19940 recalls

FDA records 1 decision for Med-Genesis, Inc. (Great Neck,, NY) in 1994: 1 510(k) clearance. All are in product code IWS (Shield, Eye, Radiological). 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, radiology panel, where it files most

How often FDA has decided Med-Genesis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Med-Genesis, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Med-Genesis, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IWSShield, Eye, Radiological1decision

What has FDA decided for it lately?

  • K934459Med-Genesis Patient Laser Eye ShieldMed-Genesis, Inc. · 1994

The one decision as Med-Genesis, Inc. →