Zumax Medical Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Zumax Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Surgical Microscope (OMS2360, OMS2380)
1
Total
1
Cleared
0
Denied
Zumax Medical Co., Ltd. is a medical device manufacturer with a manufacturing facility in Suzhou, China. The company specializes in surgical and diagnostic equipment for healthcare professionals.
Zumax Medical has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus is Dental devices, with clearances spanning 2026. The company remains active, with its latest clearance in 2026.
Explore the company's cleared device names, product codes, and clearance dates in the database.
510(k) submissions have been managed by Suzhou Device Innovation Medical Consulting Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Zumax Medical Co., Ltd.
1 devices