FDA applicant

Bentec Medical, Inc.

Sacramento, CA3 decisions1997–20010 recalls

FDA records 3 decisions for Bentec Medical, Inc. (Sacramento, CA) from 1997 to 2001: 3 510(k) clearances. Most are in product codes EWD (Protector, Hearing (Insert)) and EMX (Balloon, Epistaxis). 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 Bentec Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Bentec Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?