Cardiovascular › Prosthetic

Which Manufacturers in China Work in This Section?

11 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Beijing, and 2 other provinces. 2 of them are contract manufacturers. Chinese manufacturers are registered for 6 of 52 device types here.

1 of those 6 device types need no premarket submission before sale in the United States. The FDA has recorded 551 recalls across the section’s product codes; the root causes it names most often are Equipment maintenance (71), Process design (42) and Process control (42).