Genadyne Biotechnologies, Inc. - FDA 510(k) Cleared Devices

Genadyne Biotechnologies, Inc. specializes in advanced wound care solutions, particularly General & Plastic Surgery devices. Headquartered on Long Island, New York, the company manufactures and assembles products in the U.S. with a registered facility in Hicksville. Genadyne focuses on Negative Pressure Wound Therapy (NPWT) systems and advanced wound dressings, distributing globally across over 50 countries.

The company has received 19 FDA 510(k) clearances from 19 total submissions since its first clearance in 2008. General & Plastic Surgery devices represent 79% of its regulatory submissions. Genadyne remains actively cleared, with the most recent FDA 510(k) clearance in 2026, demonstrating ongoing product innovation and market presence.

Recent cleared devices include the XLR8 and XLR8 Plus NPWT systems, UNO and UNO Plus single and multi-patient systems, the DUO NPWT with instillation capability, and specialized foam dressings including hybrid and white PVA formulations. The company emphasizes proprietary technologies such as its Green Foam dressing and innovative suction port design.

Genadyne maintains compliance with the MDSAP Program and ISO 13485 standards, with CE certification for international markets. Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.