Product code HQX— Ophthalmic
CODERE-DURETTE ORBITAL FLOOR IMPLANT
- Classification name
- Implant, Orbital, Extra-Ocular
- Device class
- Class 2
- Regulation
- 21 CFR 886.3340
- Advisory panel
- Ophthalmic
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code HQX
FDA has cleared devices under product code HQX between 1980 and 2003, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2003
- 1998
- 1996
- 1995
- 1990
- 1987
- 1983
- 1980
Top applicants under product code HQX
Recent clearances under product code HQX
- K023481 — MICROVISION SCLERAL BUCKLING COMPONENTS
- K983581 — OCU-GUARD AND OCU-GUARD SUPPLE
- K980816 — RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
- K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
- K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
- K950599 — STORS SCLERAL SPONGE II (LINCOFF DESIGN)
- K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
- K902308 — TAMCENAN OCULAR EXPLANTS AND BANDS
- K901002 — O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES
- K900929 — PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL
- K900927 — CODERE-DURETTE ORBITAL FLOOR IMPLANT
- K900928 — COX MALAR EMINENCE IMPLANTS
- K900930 — SPIVEY-ALLEN ORBITAL FLOOR IMPLANT
- K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
- K832481 — SCLERAL BUCKLING IMPLANTS DIF/TYPES
- K800140 — SILASTIC SCLERAL SPONGE II W/CIRCLING BD
Data sourced from openFDA. This site is unofficial and independent of the FDA.