Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
158
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePMay 20, 2026
K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System May 11, 2026
K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsApril 16, 2026
K252182SV70 Ventilator (SV70)April 6, 2026
K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, ResoFebruary 11, 2026
K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/FibroDecember 3, 2025
K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, CNovember 7, 2025
K251820ViewMateTM Ultrasound SystemSeptember 12, 2025
K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)September 5, 2025
K243767SV600, SV800 VentilatorAugust 28, 2025
K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound SysteAugust 22, 2025
K242728BeneVision Central Monitoring SystemJuly 31, 2025
K250024TE Air Diagnostic Ultrasound SystemMay 30, 2025
K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic UltrasMay 19, 2025
K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound SysteMay 16, 2025
K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, ResoNovember 8, 2024
K240375V80 Anesthetic Vaporizer (V80)October 31, 2024
K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 ElSeptember 16, 2024
K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound SySeptember 12, 2024
K240906TE Air Diagnostic Ultrasound SystemJuly 23, 2024