510(k) Report

FDA applicant

Union Medico Aps

Copenhagen, DK1 decision2005–20050 recalls

FDA records 1 decision for Union Medico Aps (Copenhagen, DK) in 2005: 1 510(k) clearance. All are in product code KZH (Introducer, Syringe Needle). Its devices cite 2 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, general hospital panel, where it files most

How often FDA has decided Union Medico Aps’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Union Medico Aps since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Union Medico Aps’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?

  • KZHIntroducer, Syringe Needle1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033696Personal InjectorUnion Medico Aps · 20052cite it

What has FDA decided for it lately?

  • K033696Personal InjectorUnion Medico Aps · 2005

The one decision as Union Medico Aps →

Other applicant names beginning “Union”

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

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