510(k) Report

FDA applicant

Medical Device Manufacturer (Thailand), Ltd.

Rayong, TH2 decisions2005–20070 recalls

FDA records 2 decisions for Medical Device Manufacturer (Thailand), Ltd. (Rayong, TH) from 2005 to 2007: 2 510(k) clearances. All are in product code MEG (Syringe, Antistick). Its devices cite 3 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, general hospital panel, where it files most

How often FDA has decided Medical Device Manufacturer (Thailand), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Device Manufacturer (Thailand), Ltd. 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?

  • MEGSyringe, Antistick2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K051694Clickzip Needle Retractable Safety SyringeMedical Device Manufacturer (Thailand), Ltd. · 20051cites it

What has FDA decided for it lately?

  • K062780Clickzip, Model U-100 Insulin Safety SyringeMedical Device Manufacturer (Thailand), Ltd. · 2007
  • K051694Clickzip Needle Retractable Safety SyringeMedical Device Manufacturer (Thailand), Ltd. · 2005

All 2 as Medical Device Manufacturer (Thailand), Ltd. →