FDA applicant

Mitek Products

Westwood, MA30 decisions1996–20022 recalls

FDA records 30 decisions for Mitek Products (Westwood, MA) from 1996 to 2002: 30 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 30 predicates, 10 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Mitek Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mitek Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 Worldwide 10 Mitek, Inc. 1

Mitek Products

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Mitek”