510(k) Report

FDA applicant

Tfs Manufacturing Pty, Ltd.

North Plympton Sa, AU1 decision2005–20050 recalls

FDA records 1 decision for Tfs Manufacturing Pty, Ltd. (North Plympton Sa, AU) in 2005: 1 510(k) clearance. All are in product code FTL (Mesh, Surgical, Polymeric). 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 Tfs Manufacturing Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tfs Manufacturing Pty, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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