FDA applicant

Meditec Co., Ltd.

Sunnamcity, Kyunggido, KR8 decisions1983–20040 recalls

FDA records 8 decisions for Meditec Co., Ltd. (Sunnamcity, Kyunggido, KR) from 1983 to 2004: 8 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and GEX (Powered Laser Surgical Instrument). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Meditec, Inc.”.

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 Meditec Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Meditec Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Meditec”

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

Meditec of America 2

Meditec Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Meditec”