510(k) Report

FDA applicant

Palex Intl. SA

Spain, ES5 decisions1990–19910 recalls

FDA records 5 decisions for Palex Intl. SA (Spain, ES) from 1990 to 1991: 5 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). 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, anesthesiology panel, where it files most

How often FDA has decided Palex Intl. SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Palex Intl. SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Palex”

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