510(k) Report

FDA applicant

Precision Medical Plastics, Ltd.

Shenzhen, CN1 decision2024–20240 recalls

FDA records 1 decision for Precision Medical Plastics, Ltd. (Shenzhen, CN) in 2024: 1 510(k) clearance. All are in product code DXT (Injector And Syringe, Angiographic). 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Precision Medical Plastics, Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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