FDA applicant

Australian Biomedical Corporation, Ltd.

Australia, AU5 decisions1985–19870 recalls

FDA records 5 decisions for Australian Biomedical Corporation, Ltd. (Australia, AU) from 1985 to 1987: 5 510(k) clearances. Most are in product codes IDZ (Cassettes, Tissue) and GAD (Retractor). 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, pathology panel, where it files most

How often FDA has decided Australian Biomedical Corporation, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Australian Biomedical Corporation, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Australian Biomedical Corporation, 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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Other applicant names beginning “Australian”

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

Australian Optical Co., Inc. 8 Australian Surgical Design & Manufacture 1 Australian Surgical Devices 1

Australian Biomedical Corporation, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Australian”