FDA applicant

Oryx Medical Pty, Ltd.

Maylands, AT1 decision2012–20120 recalls

FDA records 1 decision for Oryx Medical Pty, Ltd. (Maylands, AT) in 2012: 1 510(k) clearance. All are in product code LCC (Applicator, Ocular Pressure). 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Oryx Medical Pty, Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oryx Medical 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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Other applicant names beginning “Oryx”

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

Oryx Dental Software, Inc. 1

Oryx Medical Pty, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Oryx”