510(k) Report

FDA applicant

Rusin Medical Devices

Anoka, MN1 decision2002–20020 recalls

FDA records 1 decision for Rusin Medical Devices (Anoka, MN) in 2002: 1 510(k) clearance. All are in product code NHM (Sheet, Recording, Breast Examination). 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 Rusin Medical Devices’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rusin Medical Devices since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rusin Medical Devices’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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