FDA applicant

Compex, Spol, S.R.O.

Brno, CZ2 decisions2023–20250 recalls

FDA records 2 decisions for Compex, Spol, S.R.O. (Brno, CZ) from 2023 to 2025: 2 510(k) clearances. Most are in product codes QVJ (Low Power Electrosurgical Devices For Skin…) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 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 and plastic surgery panel, where it files most

How often FDA has decided Compex, Spol, S.R.O.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Compex, Spol, S.R.O. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Compex, Spol, S.R.O.’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 “Compex”

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

Compex Technologies, Inc. 2 Compex S.A. 1

Compex, Spol, S.R.O.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Compex”