Gelflex is one of 160 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Gelflex - FDA 510(k) Cleared Devices
Recent clearances: GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT, GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS
2
Total
2
Cleared
0
Denied
Gelflex has 2 FDA 510(k) cleared medical devices. Based in Perth, AU.
Historical record: 2 cleared submissions from 2001 to 2003. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Gelflex Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Gelflex
2 devices