510(k) Report

FDA applicant

Great Bay Medical Products, Inc.

Dover, NH1 decision1994–19940 recalls

FDA records 1 decision for Great Bay Medical Products, Inc. (Dover, NH) in 1994: 1 510(k) clearance. All are in product code KCZ (Prosthesis, Breast, External, Used With Adhesive). 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, general and plastic surgery panel, where it files most

How often FDA has decided Great Bay Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Great Bay Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • KCZProsthesis, Breast, External, Used With Adhesive1decision

What has FDA decided for it lately?

  • K933465CosmetGreat Bay Medical Products, Inc. · 1994

The one decision as Great Bay Medical Products, Inc. →

Other applicant names beginning “Great”

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

Great Lakes Orthodontics, Ltd. 13Great Batch Medical 11Great Glove Sdn Bhd 4Great Basin Scientific, Inc. 4Great Glove (China), Inc. 2Great Eastern Lumber Co., Inc. 2Great Glove (Thailand) Co., Ltd. 2Great Field Industries Co., Ltd. 1Great Eco Glove Sdn. Bhd. 1Great Future Works, Ltd. 1Great Lakes Intl. 1Great West Medical Equipment, Inc. 1