FDA applicant

Mitek Surgical Products, Inc.

Norwood, MA31 decisions1989–19960 recalls

FDA records 31 decisions for Mitek Surgical Products, Inc. (Norwood, MA) from 1989 to 1996: 31 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and GAS (Suture, Nonabsorbable, Synthetic, Polyester). 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 Surgical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mitek Surgical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mitek Surgical Products, 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 Products 30 Mitek Worldwide 10 Mitek, Inc. 1

Mitek Surgical Products, Inc.

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 “Mitek”