FDA applicant

Apdyne Medical Co.

Saint Paul, MN2 decisions1989–19910 recalls

FDA records 2 decisions for Apdyne Medical Co. (Saint Paul, MN) from 1989 to 1991: 2 510(k) clearances. Most are in product codes KCJ (Applicator, Ent) and JOH (Tube Tracheostomy And Tube Cuff). 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, ear, nose and throat panel, where it files most

How often FDA has decided Apdyne Medical Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Apdyne Medical Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Apdyne Medical Co.

Which product codes does it file in?

What has FDA decided for it lately?