FDA applicant

Union Medical Engeneering Co., Ltd.

Miami, FL2 decisions1999–20000 recalls

FDA records 2 decisions for Union Medical Engeneering Co., Ltd. (Miami, FL) from 1999 to 2000: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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 Union Medical Engeneering Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Union Medical Engeneering Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Union Medical Engeneering Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Union Medical Engeneering Co., Ltd.’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

Other applicant names beginning “Union”

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

Union Carbide Corp. 69 Union Broach, Div. Moyco Industries, Inc. 14 Union Industrial Co., Ltd. 3 Union Rubber Gloves Co., Ltd. 2 Union Surgical, LLC 2 Union Branch 2 Union Medical Shenzhen Co., Ltd. 1 Union Dental S.A./Unidesa.Odi 1 Union License Ent. Co., Ltd. 1 Union Dental S.A. 1 Union Medico Aps 1 Union Medical USA 1

Union Medical Engeneering Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Union”