510(k) Report

FDA applicant

Great West Medical Equipment, Inc.

West Vancouver, B.C., CA1 decision1991–19910 recalls

FDA records 1 decision for Great West Medical Equipment, Inc. (West Vancouver, B.C., CA) in 1991: 1 510(k) clearance. All are in product code MCY (Wound Dressing Kit). 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Great West Medical Equipment, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Great West Medical Equipment, 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?

  • MCYWound Dressing Kit1decision

What has FDA decided for it lately?

  • K912684Home Medical Kit - for Little HurtsGreat West Medical Equipment, Inc. · 1991

The one decision as Great West Medical Equipment, 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 Bay Medical Products, Inc. 1