FDA applicant

Mitek Worldwide

Norwood, MA10 decisions2002–20040 recalls

FDA records 10 decisions for Mitek Worldwide (Norwood, MA) from 2002 to 2004: 10 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and JDR (Staple, Fixation, Bone). Its devices cite 18 predicates, 0 of them its own earlier devices. 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Mitek Worldwide since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mitek Worldwide 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, Inc. 1

Mitek Worldwide

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?

Other applicant names beginning “Mitek”