Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - FDA 510(k) Clear...
Recent clearances: ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC), Diagnostic Ultrasound System (MU9), uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
158
Total
158
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Radiology ✕
100 devices
Cleared
May 11, 2026
Diagnostic Ultrasound System (MU9)
Radiology
56d
Cleared
Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
Radiology
142d
Cleared
Dec 03, 2025
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus...
Radiology
190d
Cleared
Nov 07, 2025
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER,...
Radiology
143d
Cleared
Sep 12, 2025
ViewMateTM Ultrasound System
Radiology
91d
Cleared
Sep 05, 2025
ViewMate™ Multi Ultrasound System (VMM-ICE-01)
Radiology
135d
Cleared
Aug 22, 2025
Diagnostic Ultrasound System (MX7)
Radiology
127d
Cleared
May 30, 2025
TE Air Diagnostic Ultrasound System
Radiology
144d
Cleared
May 19, 2025
Diagnostic Ultrasound System (Recho R9W)
Radiology
136d
Cleared
May 16, 2025
Diagnostic Ultrasound System (MX6)
Radiology
120d
Cleared
Nov 08, 2024
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
Radiology
101d
Cleared
Sep 16, 2024
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10...
Radiology
139d
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