510(k) Report

FDA applicant

Emsee Lab of Florida

Palm Harbor, FL3 decisions1994–19940 recalls

FDA records 3 decisions for Emsee Lab of Florida (Palm Harbor, FL) in 1994: 3 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Emsee Lab of Florida’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Emsee Lab of Florida since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription3decisions

What has FDA decided for it lately?

  • K944984Emsee Labs Model SEmsee Lab of Florida · 1994
  • K944986Emsee Labs Model CEmsee Lab of Florida · 1994
  • K944985Emsee Labs Mode MEmsee Lab of Florida · 1994

All 3 as Emsee Lab of Florida →