O'Neill is one of 25969 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
O'Neill - FDA 510(k) Cleared Devices
Recent clearances: SUPINE STRESS SYSTEM
1
Total
1
Cleared
0
Denied
O'Neill, is a California-based apparel and lifestyle brand with a manufacturing facility in McHenry, US. The company is known for surf and water sports clothing, wetsuits, and accessories.
O'Neill has a historical FDA 510(k) regulatory record in Physical Medicine devices. The company received 1 FDA 510(k) clearance from 1 total submission, with its clearance dating to 1981. This represents a historical record only; the company has not pursued FDA clearances in recent years.
The cleared device was the SUPINE STRESS SYSTEM, a Physical Medicine device. For detailed information on device names, product codes, and clearance dates, consult the FDA 510(k) database.
FDA 510(k) Regulatory Record - O'Neill
1 devices