510(k) Report

FDA applicant

Veraxis Int'L, Inc.

New York, NY1 decision2006–20060 recalls

FDA records 1 decision for Veraxis Int'L, Inc. (New York, NY) in 2006: 1 510(k) clearance. All are in product code HIS (Condom). 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 Veraxis Int'L, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Veraxis Int'L, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Veraxis Int'L, 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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