Data / Medical devices / South Korea / Samsung Medison Co., Ltd.

Samsung Medison Co., Ltd.: FDA-registered device maker in HONGCHEON-GUN Gangwon, South Korea, 78 510(k) clearances

Samsung Medison Co., Ltd. is registered with the FDA (registration 8041160) in HONGCHEON-GUN Gangwon, South Korea. It lists 7 device types. The FDA files 78 510(k) clearances under its listings, the newest dated October 8, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number

8041160

FEI number

3010289997

Address

3366, Hanseo-ro, Nam-myeon, HONGCHEON-GUN Gangwon, South Korea, 25108

Owner or operator

SAMSUNG MEDISON CO., LTD. (8041160)

Roles

Manufacturer

First device listed

July 18, 2010

Registered through

2027

Brand names listed

3D/5D Viewer, 5D Viewer, A35, ACCUVIX A30, ACCUVIX XG, EKO 7, EVO Q10 Diagnostic Ultrasound System, EVO Q20 Diagnostic Ultrasound System and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

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Updated October 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.