FDA applicant

Medison Co., Ltd.

Seoul, KR24 decisions1990–20110 recalls

FDA records 24 decisions for Medison Co., Ltd. (Seoul, KR) from 1990 to 2011: 24 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 39 predicates, 28 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, radiology panel, where it files most

How often FDA has decided Medison Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007high 5 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medison 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 “Medison”

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

Medison America, Inc. 21 Medison Radiology Systems, Inc. 2

Medison 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 “Medison”