510(k) Report

FDA applicant

Umeco Union Medical Engineering

Miami, FL1 decision1998–19980 recalls

FDA records 1 decision for Umeco Union Medical Engineering (Miami, FL) in 1998: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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 Umeco Union Medical Engineering’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Umeco Union Medical Engineering since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Umeco”

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