510(k) Report

FDA applicant

Levtrade Intl. (Pty), Ltd.

Petoria, South Africa, ZA4 decisions1993–19940 recalls

FDA records 4 decisions for Levtrade Intl. (Pty), Ltd. (Petoria, South Africa, ZA) from 1993 to 1994: 4 510(k) clearances. Most are in product codes FPY (Sheet, Burn) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). 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 Levtrade Intl. (Pty), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Levtrade Intl. (Pty), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Levtrade Intl. (Pty), Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Levtrade Intl. (Pty), Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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