Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - FDA 510(k) Clear...
Recent clearances: A5 Anesthesia System (A5), 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)
159
Total
159
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Cardiovascular ✕
37 devices
Cleared
May 20, 2026
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM...
Cardiovascular
127d
Cleared
Apr 16, 2026
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
Cardiovascular
202d
Cleared
Jul 31, 2025
BeneVision Central Monitoring System
Cardiovascular
324d
Cleared
Dec 02, 2022
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
Cardiovascular
231d
Cleared
Jul 12, 2022
N Series Patient Monitors
Cardiovascular
218d
Cleared
Jun 01, 2022
BeneVision Central Monitoring System
Cardiovascular
146d
Cleared
Oct 05, 2021
Vital Signs Monitors
Cardiovascular
146d
Cleared
Jan 07, 2021
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision...
Cardiovascular
139d
Cleared
Jun 08, 2020
ePM Series Patient monitors
Cardiovascular
157d
Cleared
May 21, 2020
BeneVision Central Monitoring System
Cardiovascular
167d
Cleared
May 07, 2020
Patient Monitor
Cardiovascular
196d
Cleared
Oct 31, 2019
ePM Series Patient monitors
Cardiovascular
122d
Looking for a specific device from Shenzhen Mindray...? Search by device name or K-number.
Search all Shenzhen Mindray... devices