Fziomed, Inc. - FDA 510(k) Cleared Devices

Fziomed, Inc. is a global leader in postsurgical adhesion prevention. The company develops and manufactures innovative absorbable gel barrier products designed to reduce postoperative adhesion formation across multiple surgical specialties. Fziomed operates with a manufacturing facility in San Luis Obispo, California, and has treated over one million patients worldwide since 2002.

The company has received 1 FDA 510(k) clearance from 2 total submissions. All submissions focus on Orthopedic devices. The most recent clearance was in 2026, demonstrating continued regulatory activity and product innovation in this category.

Fziomed's proprietary dual-polymer gel technology serves multiple surgical applications, including spine, tendon and peripheral nerve repair, intrauterine procedures, and abdominal or pelvic surgery. The company's products are manufactured in the United States and designed to work with the body's natural healing process.

Explore the company's FDA 510(k) clearance history, device names, product codes, and clearance dates in the regulatory database.

510(k) submissions have been managed by DuVal & Associates, P.A. as regulatory consultant.