FDA applicant

Hyunjae Corp.

New Milford, CT2 decisions1996–19970 recalls

FDA records 2 decisions for Hyunjae Corp. (New Milford, CT) from 1996 to 1997: 2 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and ELW (Material, Impression). 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 Hyunjae Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hyunjae Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hyunjae Corp.

Which product codes does it file in?

What has FDA decided for it lately?