HQX · Class II · 21 CFR 886.3340

FDA Product Code HQX: Implant, Orbital, Extra-ocular

Leading manufacturers include Fci Ophthalmics, Inc., Dow Corning Corp. Healthcare Industries Materials and Storz Instrument Co..

16
Total
16
Cleared
101d
Avg days
1980
Since

FDA 510(k) Cleared Implant, Orbital, Extra-ocular Devices (Product Code HQX)

16 devices
1–16 of 16
Cleared Nov 06, 1998
OCU-GUARD AND OCU-GUARD SUPPLE
K983581
Bio-Vascular, Inc.
Ophthalmic · 24d
Cleared Sep 18, 1998
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
K980816
Fci Ophthalmics, Inc.
Ophthalmic · 199d
Cleared Oct 28, 1996
RETINAL DETACHMENT IMPLANTS
K963219
Fci Ophthalmics, Inc.
Ophthalmic · 73d
Cleared Jun 05, 1996
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
K950806
Mira, Inc.
Ophthalmic · 469d
Cleared Jan 17, 1995
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
K945172
Visitec Co.
Ophthalmic · 88d
Cleared Sep 20, 1983
SCLERAL BUCKLING IMPLANTS DIF/TYPES
K832481
Storz Instrument Co.
Ophthalmic · 56d
Cleared Mar 03, 1980
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
K800140
Dow Corning Corp. Healthcare Industries Materials
Ophthalmic · 42d

About Product Code HQX - Regulatory Context