ClearanceBrief
Company ยท KR

Samsung Medison Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.

75510(k) clearances (5 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic70
LLZSystem, Image Processing, Radiological4
IYOSystem, Imaging, Pulsed Echo, Ultrasonic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 8, 2026K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic U
Samsung Medison Co., Ltd., KR
IYN
Sep 25, 2026K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP
Samsung Medison Co., Ltd., KR
IYN
Jul 28, 2026K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H
Samsung Medison Co., Ltd., KR
IYN
Mar 27, 2026K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ
Samsung Medison Co., Ltd., KR
IYN
Jan 5, 2026K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R
Samsung Medison Co., Ltd., KR
IYN
Jul 18, 2025K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultra
Samsung Medison Co., Ltd., KR
IYN
Feb 12, 2025K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultra
Samsung Medison Co., Ltd., KR
IYN
Dec 10, 2024K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultra
Samsung Medison Co., Ltd., KR
IYN
Nov 27, 2024K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Oct 11, 2024K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 23, 2024K241302SonoSync
Samsung Medison Co., Ltd., KR
LLZ
Jun 21, 2024K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 12, 2024K240516RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 21, 2023K233112HM70 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Oct 3, 2023K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Apr 21, 2023K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 13, 2023K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 22, 2022K221599HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 29, 2022K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 17, 2022K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 6, 2022K220269HM70 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KP
IYN
Apr 5, 2022K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 9, 2021K211824HERA W9, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 8, 2021K211945V8 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jul 9, 2021K210713HM70 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 24, 2021K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 13, 2021K210426HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Apr 9, 2021K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Oct 30, 2020K202556HS30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 7, 2020K200699HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Apr 7, 2020K200339HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jan 6, 2020K192903RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 12, 2019K192505HS50/HS60 Diagnostics Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 10, 2019K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 19, 2019K192030RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 12, 2019K191115RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 12, 2019K191055HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 22, 2019K190444HERA I10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 15, 2019K182932RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jan 22, 2019K182894HM70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jan 8, 2019K182632HS30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 18, 2018K182595HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 4, 2018K181336HS50 / HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 15, 2018K1808835D Viewer
Samsung Medison Co., Ltd., KR
LLZ
May 11, 2018K180409HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Mar 8, 2018K173713HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 20, 2018K173513WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 5, 2018K173204RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 24, 2017K171048RS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 9, 2017K171070WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN

Newest 50 of 75.

Latest recalls

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