FDA applicant

Goldway Us, Inc.

San Jose, CA4 decisions2003–20120 recalls

FDA records 4 decisions for Goldway Us, Inc. (San Jose, CA) from 2003 to 2012: 4 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and HEX (Colposcope (And Colpomicroscope)). Its devices cite 9 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Goldway (Us), Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Goldway Us, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Goldway Us, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Goldway Us, Inc.’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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Goldway Us, Inc.

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?