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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 1985 | K852774 | OCULAB TONOPEN Oculab, Inc. | HKY |
| Mar 5, 1984 | K834187 | JAKOBI SURG. INSTRUMENTS #6 50 Imm Enterprises , Ltd. | HKY |
| Nov 28, 1983 | K832996 | SURGICAL IOP MONITOR Miami Eye Technology, Inc. | HKY |
| Feb 24, 1982 | K813619 | CONPHAR-SCHIOETZ TONOMETER Conphar, Inc. | HKY |
| Sep 27, 1978 | K781105 | TONOMETER, DIGITON Ical, Inc. | HKY |
| Nov 28, 1977 | K772130 | OCULAR CEREBRAL VASCULAR MONITOR Digilab, Inc. | HKY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.