Molnlycke Health Care - FDA 510(k) Cleared Devices

Mölnlycke Health Care is a world-leading medical technology company dedicated to improving quality of life for patients and caregivers. The company offers innovative, high-quality solutions for wound care and surgical procedures, with a manufacturing facility in Newton, US.

Mölnlycke has received 9 FDA 510(k) clearances from 9 total submissions, with no denied submissions on record. The company's cleared devices span General & Plastic Surgery and General Hospital categories, including advanced wound dressings, surgical drapes, and protective equipment. Clearances were granted between 2003 and 2014.

Notable cleared products include the AVANCE® FOAM ABDOMINAL DRESSING KIT, MEPITEL AG, MEPILEX series absorbent silicone-coated dressings, BARRIER SURGICAL GOWNS, and KLINIDRAPE SURGICAL DRAPES. These devices reflect the company's core expertise in wound management and surgical site protection.

This company profile represents a historical regulatory record. For detailed device names, product codes, and specific clearance dates, explore the complete 510(k) submission history.