Samsung Medison Co., Ltd. - FDA 510(k) Cleared Devices
71
Total
71
Cleared
0
Denied
FDA 510(k) cleared devices by Samsung Medison Co., Ltd. Radiology ✕
71 devices
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
Cleared
Apr 21, 2023
HERA W10 Diagnostic Ultrasound System
Radiology
100d
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