FDA Product Code
FDA Product Code HQX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.3340
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | Microvision, Inc. | 2003-01-08 | Traditional | PDF ↗ |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | 1998-11-06 | Special | PDF ↗ |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Fci Ophthalmics, Inc. | 1998-09-18 | Traditional | PDF ↗ |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Fci Ophthalmics, Inc. | 1996-10-28 | Traditional | PDF ↗ |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | 1996-06-05 | Traditional | PDF ↗ |
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Storz Ophthalmics, Inc. | 1995-03-02 | Traditional | PDF ↗ |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Visitec Co. | 1995-01-17 | Traditional | PDF ↗ |
| K902308 | TAMCENAN OCULAR EXPLANTS AND BANDS | Tamcenan Corp. | 1990-06-19 | Traditional | PDF ↗ |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | Oculo Plastik, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | Oculo Plastik, Inc. | 1990-05-18 | Traditional | PDF ↗ |
| K900928 | COX MALAR EMINENCE IMPLANTS | Oculo Plastik, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Porex Medical | 1987-02-27 | Traditional | PDF ↗ |
| K832481 | SCLERAL BUCKLING IMPLANTS DIF/TYPES | Storz Instrument Co. | 1983-09-20 | Traditional | PDF ↗ |
| K800140 | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | Dow Corning Corp. Healthcare Industries Materials | 1980-03-03 | Traditional | PDF ↗ |
Product code HQX · Class II · Ophthalmic. Data: openFDA.