510(k) Report

FDA applicant

Metron Medical Australia, Pty, Ltd.

Carrum Downs, AU17 decisions1999–20130 recalls

FDA records 17 decisions for Metron Medical Australia, Pty, Ltd. (Carrum Downs, AU) from 1999 to 2013: 17 510(k) clearances. Most are in product codes IMI (Ultrasonic Diathermy For Use In Applying…) and IPF (Stimulator, Muscle, Powered). 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, physical medicine panel, where it files most

How often FDA has decided Metron Medical Australia, Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2012: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Metron”

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