Samsung Medison Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
71
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic January 5, 2026
K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; July 18, 2025
K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; February 12, 2025
K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, December 10, 2024
K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemNovember 27, 2024
K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemOctober 11, 2024
K241302SonoSyncAugust 23, 2024
K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemJune 21, 2024
K240516RS85 Diagnostic Ultrasound SystemJune 12, 2024
K233112HM70 EVO Diagnostic Ultrasound SystemDecember 21, 2023
K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound October 3, 2023
K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemApril 21, 2023
K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemFebruary 13, 2023
K221599HS40 Diagnostic Ultrasound SystemAugust 22, 2022
K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemJune 29, 2022
K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemJune 17, 2022
K220269HM70 EVO Diagnostic Ultrasound SystemMay 6, 2022
K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemApril 5, 2022
K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSeptember 9, 2021
K211945V8 Diagnostic Ultrasound SystemSeptember 8, 2021