Convatec Limited - FDA 510(k) Cleared Devices

Convatec Limited, is a global medical device manufacturer specializing in chronic disease management solutions. The company operates with a manufacturing facility in Deeside, United Kingdom, and serves patients and healthcare professionals worldwide through innovative product portfolios.

Convatec has received 9 FDA 510(k) clearances from 10 total submissions since 2016. The company's cleared devices span Gastroenterology & Urology and General & Plastic Surgery categories, with a strong focus on intermittent urinary catheters, fecal management systems, and advanced wound care dressings. The latest clearance in 2025 demonstrates continued regulatory activity and product innovation.

The company's portfolio includes hydrophilic intermittent catheters, negative pressure wound therapy systems, and hydrofiber dressings with antimicrobial properties. These devices address critical clinical needs in continence care, wound management, and surgical applications. Convatec's product range reflects deep expertise in both urology and wound healing technologies.

Explore the complete list of device names, 510(k) submission numbers, and clearance dates in the database to review Convatec's full regulatory history and cleared device portfolio.