Panels › Ophthalmic › Product code HJI · Class 1
Lens, Fundus, Hruby, Diagnostic
Regulation 886.1395
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HJI
| Company | 510(k)s | Recalls |
|---|---|---|
| Cooper Medical Devices Corp. | 2 | 0 |
| Academic Catalyst Corp. | 1 | 0 |
| Canon USA, Inc. | 1 | 0 |
| Innovision Medical, Inc. | 1 | 0 |
| Ocular Instruments, Inc. | 1 | 0 |
| Optical Micro Systems, Inc. | 1 | 0 |
| Richard'S Medical Equip., Inc. | 1 | 0 |
| Volk Optical Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 1992 | K923670 | BYRNE EXPULSIVE LENS Ocular Instruments, Inc. | HJI |
| Jul 5, 1990 | K902138 | STRIPE PROJECTOR Academic Catalyst Corp. | HJI |
| Jul 5, 1990 | K901839 | 60 FUNDUS CAMERA CF-60UV Canon USA, Inc. | HJI |
| Mar 12, 1990 | K897186 | LASER IMAGING WORK STATION Innovision Medical, Inc. | HJI |
| Feb 5, 1982 | K820223 | OMS QUARTZ INFUSION CONTACT LENS Optical Micro Systems, Inc. | HJI |
| Feb 5, 1981 | K802971 | LANDERS CONTACT LENS Cooper Medical Devices Corp. | HJI |
| Feb 5, 1981 | K802927 | SEBESTYEN IRRIGATING CONTACT LENS Cooper Medical Devices Corp. | HJI |
| Nov 11, 1976 | K760949 | CHARLES IRRIGATING FUNDUS CONTACT LENS Richard'S Medical Equip., Inc. | HJI |
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