510(k) Report

FDA applicant

Misten Medical Corp.

Germantown, TN4 decisions1995–19960 recalls

FDA records 4 decisions for Misten Medical Corp. (Germantown, TN) from 1995 to 1996: 4 510(k) clearances. Most are in product codes ETD (Tube, Tympanostomy) and ETB (Prosthesis, Partial Ossicular Replacement). 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 Misten Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Misten Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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