W.L. Gore & Associates is one of 20418 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
W.L. Gore & Associates - FDA 510(k) Cleared Devices
Recent clearances: GORE(R) EMBOLIC FILTER, GORE HYBRID VASCULAR GRAFT, GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
3
Total
3
Cleared
0
Denied
W.L. Gore & Associates, is a medical device manufacturer with a manufacturing facility in Flagstaff, US. The company specializes in advanced medical technologies across multiple therapeutic areas.
The company has received 3 FDA 510(k) clearances from 3 total submissions. Its cleared devices span cardiovascular and surgical specialties, with clearances granted between 2005 and 2012. This represents a historical regulatory record; the company has not received clearances in more than a decade.
Notable cleared devices include vascular grafts, embolic filters, and surgical reinforcement materials. These products reflect the company's focus on cardiovascular interventions and surgical applications requiring specialized biomaterials and engineering.
Explore the complete clearance history, device names, product codes, and approval dates in the database records below.
FDA 510(k) Regulatory Record - W.L. Gore & Associates
3 devices