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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2015 | Volk Optical Inc Lombart 90D Clear with case
Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp. Terminated |
HJI | None listed |
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