Panels › Ophthalmic › Product code HQX · Class 2
Implant, Orbital, Extra-Ocular
Regulation 886.3340
0510(k)s in 12 months (16 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in HQX
| Company | 510(k)s | Recalls |
|---|---|---|
| Gulden Ophthalmics | 0 | 13 |
| Oculo Plastik, Inc. | 5 | 0 |
| Fci Ophthalmics, Inc. | 2 | 0 |
| Bio-Vascular, Inc. | 1 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 1 | 0 |
| Microvision, Inc. | 1 | 0 |
| Mira, Inc. | 1 | 0 |
| Porex Medical | 1 | 0 |
| Storz Instrument Co. | 1 | 0 |
| Storz Ophthalmics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 8, 2003 | K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS Microvision, Inc. | HQX |
| Nov 6, 1998 | K983581 | OCU-GUARD AND OCU-GUARD SUPPLE Bio-Vascular, Inc. | HQX |
| Sep 18, 1998 | K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES Fci Ophthalmics, Inc. | HQX |
| Oct 28, 1996 | K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES Fci Ophthalmics, Inc. | HQX |
| Jun 5, 1996 | K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS Mira, Inc. | HQX |
| Mar 2, 1995 | K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) Storz Ophthalmics, Inc. | HQX |
| Jan 17, 1995 | K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS Visitec Co. | HQX |
| Jun 19, 1990 | K902308 | TAMCENAN OCULAR EXPLANTS AND BANDS Tamcenan Corp. | HQX |
| May 22, 1990 | K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES Oculo Plastik, Inc., CA | HQX |
| May 18, 1990 | K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL Oculo Plastik, Inc., CA | HQX |
| May 15, 1990 | K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT Oculo Plastik, Inc., CA | HQX |
| May 15, 1990 | K900928 | COX MALAR EMINENCE IMPLANTS Oculo Plastik, Inc., CA | HQX |
| May 15, 1990 | K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT Oculo Plastik, Inc., CA | HQX |
| Feb 27, 1987 | K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT Porex Medical | HQX |
| Sep 20, 1983 | K832481 | SCLERAL BUCKLING IMPLANTS DIF/TYPES Storz Instrument Co. | HQX |
| Mar 3, 1980 | K800140 | SILASTIC SCLERAL SPONGE II W/CIRCLING BD Dow Corning Corp. Healthcare Industries Materials | HQX |
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