Medical Device Manufacturer · US , Minnetonka , MN

St Jude Medical - FDA 510(k) Cleared Devices

105 submissions · 105 cleared · Since 2000

105

Total

105

Cleared

Denied

St Jude Medical, was a global medical device company headquartered in Little Canada, Minnesota. The company operated more than 20 principal facilities worldwide and sold products in over 100 countries.

St Jude Medical received 105 FDA 510(k) clearances from 105 total submissions between 2000 and 2018. The company's regulatory focus centered on Cardiovascular devices, which represented 91% of all submissions. Notable cleared products include cardiac mapping systems, pacing catheters, and mobile cardiac applications.

Now part of Abbott Laboratories following its acquisition in January 2017, St Jude Medical's regulatory record reflects its historical role as a major innovator in cardiac and electrophysiology device technologies. The company was founded in 1976 and achieved Fortune 500 status annually since 2010.

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

FDA 510(k) Regulatory Record - St Jude Medical

105 devices

1-12 of 105