FDA applicant

Ototech, Ltd.

Minneapolis, MN5 decisions1991–20010 recalls

FDA records 5 decisions for Ototech, Ltd. (Minneapolis, MN) from 1991 to 2001: 5 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and NEA (Cement, Ear, Nose And Throat). No recall is linked to its devices.

FDA’s records also spell it “Ototech, Inc.”.

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 Ototech, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ototech, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ototech”

FDA records each applicant name separately; these may or may not be the same firm.

Ototech Intl., Inc. 1

Ototech, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ototech”