Samsung Medison Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Samsung Medison Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System, EVO Q30 Diagnostic Ultrasound System, HERA Z20 Diagnostic Ultrasound System
73
Total
73
Cleared
0
Denied
Samsung Medison Co., Ltd. has 73 FDA 510(k) cleared radiology devices. Based in Seoul, KR.
Latest FDA clearance: Jul 2026. Active since 2011.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Samsung Medison Co., Ltd.
73 devices
Cleared
Jul 28, 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound...
Radiology
89d
Cleared
Mar 27, 2026
EVO Q30 Diagnostic Ultrasound System
Radiology
98d
Cleared
Jan 05, 2026
HERA Z20 Diagnostic Ultrasound System
Radiology
189d
Cleared
Jul 18, 2025
V8 Diagnostic Ultrasound System
Radiology
108d
Cleared
Feb 12, 2025
V8 Diagnostic Ultrasound System
Radiology
75d
Cleared
Dec 10, 2024
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5...
Radiology
109d
Cleared
Nov 27, 2024
HERA W10 Diagnostic Ultrasound System
Radiology
103d
Cleared
Oct 11, 2024
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
Radiology
98d
Cleared
Aug 23, 2024
SonoSync
Radiology
106d
Cleared
Jun 21, 2024
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
Radiology
107d
Cleared
Jun 12, 2024
RS85 Diagnostic Ultrasound System
Radiology
110d
Cleared
Dec 21, 2023
HM70 EVO Diagnostic Ultrasound System
Radiology
85d
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