510(k) Report

FDA applicant

Exidyne, Inc.

Walker, MI1 decision1984–19840 recalls

FDA records 1 decision for Exidyne, Inc. (Walker, MI) in 1984: 1 510(k) clearance. All are in product code JAY (Support, Breathing Tube). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Exidyne, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Exidyne, 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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