Covidien - FDA 510(k) Cleared Devices

Covidien is an Irish-registered global healthcare products company headquartered in North Haven, Connecticut. Now part of Medtronic following a 2015 acquisition, the brand continues to operate as a major medical device manufacturer.

Covidien maintains a strong FDA 510(k) regulatory record with 126 cleared devices from 130 total submissions spanning 2008 to 2024. The company specializes in General & Plastic Surgery devices, with a dominant focus on surgical staplers, sutures, and wound closure systems. Recent clearances include advanced stapling technologies, endotracheal tubes, and fixation devices, reflecting ongoing innovation in surgical instrumentation.

The company's product portfolio encompasses core surgical tools widely used in operating rooms globally. Notable technologies include Tri-Staple stapling systems, silk sutures, circular staplers, and temperature monitoring devices across multiple surgical specialties including anesthesiology and general surgery.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database below.