Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - FDA 510(k) Clear...

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is a medical technology and solutions supplier headquartered in Shenzhen, China. The company develops diagnostic imaging, patient monitoring, and clinical care devices.

Mindray has received 158 FDA 510(k) clearances from 158 total submissions since 2004. The company specializes in diagnostic ultrasound systems and radiology devices, with a strong portfolio spanning general imaging, women's healthcare, cardiology, and liver care applications. Recent clearances include multiple ultrasound system variants and central monitoring platforms. The latest FDA 510(k) clearance in 2026 confirms active regulatory engagement.

Mindray's cleared device portfolio encompasses diagnostic ultrasound platforms, patient monitoring systems, ventilators, and cardiovascular monitoring solutions. The company maintains a broad presence across emergency care, critical care, perioperative care, and point-of-care settings.

Explore the complete list of device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Shenzhen Mindray Biomedical Electronics Co., Ltd. as regulatory consultant.