FDA applicant

Medical Insights, Inc.

Mystic, CT4 decisions1993–19940 recalls

FDA records 4 decisions for Medical Insights, Inc. (Mystic, CT) from 1993 to 1994: 4 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and KBM (Dissector, Tonsil). 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 Medical Insights, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Insights, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Medical Insights, Inc.

Which product codes does it file in?

What has FDA decided for it lately?