FDA applicant

Canyon Medical, Inc.

Nanjing, CN6 decisions2023–20260 recalls

FDA records 6 decisions for Canyon Medical, Inc. (Nanjing, CN) from 2023 to 2026: 6 510(k) clearances. Most are in product codes NEY (System, Ablation, Microwave And Accessories) and KNW (Instrument, Biopsy). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2025

2023high 3 (2024) · low 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Canyon Medical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Canyon Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Canyon”

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

Canyon Diagnostics, Inc. 9 Canyon Medical Products 3

Canyon Medical, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Canyon”