FDA applicant

Australian Surgical Design & Manufacture

Annapolis, MD1 decision2006–20060 recalls

FDA records 1 decision for Australian Surgical Design & Manufacture (Annapolis, MD) in 2006: 1 510(k) clearance. All are in product code HRY (Prosthesis, Knee, Femorotibial…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, orthopedic panel, where it files most

How often FDA has decided Australian Surgical Design & Manufacture’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Australian Surgical Design & Manufacture since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Australian Surgical Design & Manufacture by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Australian Surgical Design & Manufacture’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 Biomedical Corporation, Ltd. 5 Australian Surgical Devices 1

Australian Surgical Design & Manufacture

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Australian”