Samsung Medison Co., Ltd. - FDA 510(k) Cleared Devices
72
Total
72
Cleared
0
Denied
Samsung Medison Co., Ltd. has 72 FDA 510(k) cleared radiology devices. Based in Seoul, KR.
Latest FDA clearance: Mar 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 Samsung Medison Co., Ltd. as regulatory consultant.
72 devices
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
Cleared
Oct 03, 2023
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6...
Radiology
109d
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