510(k) Report

FDA applicant

China National Medicines C/O Havel'S

Cincinnati, OH1 decision1988–19880 recalls

FDA records 1 decision for China National Medicines C/O Havel'S (Cincinnati, OH) in 1988: 1 510(k) clearance. All are in product code GDL (Needle, Suturing, Reusable). 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 and plastic surgery panel, where it files most

How often FDA has decided China National Medicines C/O Havel'S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for China National Medicines C/O Havel'S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — China National Medicines C/O Havel'S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GDLNeedle, Suturing, Reusable1decision

What has FDA decided for it lately?

  • K881394Non-Sterile Suture NeedlesChina National Medicines C/O Havel'S · 1988

The one decision as China National Medicines C/O Havel'S →