Panels › Ophthalmic › Product code HKY · Class 2
Tonometer, Manual
Regulation 886.1930
0510(k)s in 12 months (56 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in HKY
| Company | 510(k)s | Recalls |
|---|---|---|
| Icare Finland OY | 7 | 0 |
| Keeler Limited | 4 | 0 |
| Cats Tonometer, LLC | 3 | 0 |
| Falck Medical, Inc. | 2 | 0 |
| Instrumed International, Inc. | 0 | 2 |
| Oculab, Inc. | 2 | 0 |
| Reichert, Inc. | 2 | 0 |
| Takagi Seiko Co., Ltd. | 2 | 0 |
| Accutome, Inc. | 1 | 0 |
| Automated Ophthalmics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Instrumed International, Inc. Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentati Terminated |
HKY | None listed |
| Dec 16, 2014 | Instrumed International, Inc. Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure i Terminated |
HKY | None listed |
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