Medical Device Manufacturer · US , Fairfield , NJ

Chemtex USA, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2020

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Chemtex USA, Inc. Ophthalmic ✕

2 devices

1-2 of 2

Cleared Oct 12, 2022

Aqua Naina Plus Sterile Saline Solution

Ophthalmic · 163d

Cleared May 26, 2020

Aqua Naina Sterile Saline Solution

Ophthalmic · 167d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 20, 2026