510(k) Report

FDA applicant

Shandong Weigao Group Medical Polymer Co., Ltd.

Shanghai, CN7 decisions2007–20230 recalls

FDA records 7 decisions for Shandong Weigao Group Medical Polymer Co., Ltd. (Shanghai, CN) from 2007 to 2023: 7 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 11 predicates, 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, general hospital panel, where it files most

How often FDA has decided Shandong Weigao Group Medical Polymer Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 12008: 22011: 22022: 12023: 1
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shandong Weigao Group Medical Polymer Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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