510(k) Report

FDA applicant

Unigon Industries, Inc.

Walker, MI3 decisions1981–19840 recalls

FDA records 3 decisions for Unigon Industries, Inc. (Walker, MI) from 1981 to 1984: 3 510(k) clearances. Most are in product codes DXK (Echocardiograph) and JOP (Transducer, Ultrasonic). 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, cardiovascular panel, where it files most

How often FDA has decided Unigon Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unigon Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Unigon Industries, 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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