Samsung Medison Co., Ltd.

FDA 510(k) & PMA Approved Devices — 55 products

Total Devices55

Categories2

Latest FDA decision2026-07-28

Type	Number	Device Name	Code	Date	Actions
510(k)	K211824	HERA W9, HERA W10 Diagnostic Ultrasound System	IYN	2021-09-09	View
510(k)	K211945	V8 Diagnostic Ultrasound System	IYN	2021-09-08	View
510(k)	K210713	HM70 EVO Diagnostic Ultrasound System	IYN	2021-07-09	View
510(k)	K210959	RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System	IYN	2021-06-24	View
510(k)	K210426	HS40 Diagnostic Ultrasound System	IYN	2021-05-13	View
510(k)	K210068	HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System	IYN	2021-04-09	View
510(k)	K202556	HS30 Diagnostic Ultrasound System	IYN	2020-10-30	View
510(k)	K200699	HS70A Diagnostic Ultrasound System	IYN	2020-05-07	View
510(k)	K200339	HS40 Diagnostic Ultrasound System	IYN	2020-04-07	View
510(k)	K192903	RS85 Diagnostic Ultrasound System	IYN	2020-01-06	View
510(k)	K192505	HS50/HS60 Diagnostics Ultrasound System	IYN	2019-12-12	View
510(k)	K192319	HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System	IYN	2019-12-10	View
510(k)	K192030	RS80 EVO Diagnostic Ultrasound System	IYN	2019-09-19	View
510(k)	K191055	HS40 Diagnostic Ultrasound System	IYN	2019-06-12	View
510(k)	K191115	RS85 Diagnostic Ultrasound System	IYN	2019-06-12	View
510(k)	K190444	HERA I10 Diagnostic Ultrasound System	IYN	2019-05-22	View
510(k)	K182932	RS85 Diagnostic Ultrasound System	IYN	2019-02-15	View
510(k)	K182894	HM70A Diagnostic Ultrasound System	IYN	2019-01-22	View
510(k)	K182632	HS30 Diagnostic Ultrasound System	IYN	2019-01-08	View
510(k)	K182595	HERA W10 Diagnostic Ultrasound System	IYN	2018-12-18	View

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