FDA applicant

Mitek, Inc.

Marquette, MI1 decision1986–19860 recalls

FDA records 1 decision for Mitek, Inc. (Marquette, MI) in 1986: 1 510(k) clearance. All are in product code LHQ (System, Telethermographic (Adjunctive Use)). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Mitek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mitek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Mitek”

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

Mitek Surgical Products, Inc. 31 Mitek Products 30 Mitek Worldwide 10

Mitek, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Mitek”