Medical Device Manufacturer · US , Mchenry , IL

Mentor Corp. - FDA 510(k) Cleared Devices

61 submissions · 61 cleared · Since 1977

Total

Cleared

Denied

Mentor Corp. is a surgical aesthetics and medical device company based in McHenry, US. Now part of Johnson & Johnson MedTech, the brand supplies products to plastic surgeons and specialists worldwide.

Mentor has received 61 FDA 510(k) clearances from 61 total submissions since its first clearance in 1977. The company's regulatory record spans General & Plastic Surgery, Gastroenterology & Urology, Obstetrics & Gynecology, and Radiology device categories. The latest clearance was recorded in 2013, reflecting the company's historical significance in surgical device innovation.

Mentor's product portfolio includes breast tissue expanders, surgical meshes, urological catheters and tapes, penile prostheses, and brachytherapy systems. The company is recognized for developing MemoryGel silicone gel breast implants, approved by the FDA in 2006, alongside lipoplasty equipment and tissue removal systems for reconstructive and aesthetic procedures.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database below.

FDA 510(k) Regulatory Record - Mentor Corp.

61 devices

1-12 of 61