Panels › Ophthalmic › Product code HKX · Class 2
Tonometer, Ac-Powered
Regulation 886.1930
0510(k)s in 12 months (58 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HKX
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 5 | 0 |
| Keeler Instruments, Inc. | 5 | 0 |
| Canon USA, Inc. | 2 | 0 |
| CooperVision, Inc. | 2 | 0 |
| Luneau Sas | 2 | 0 |
| Nidek, Inc. | 2 | 0 |
| Ocular Blood Flow Laboratories, Inc. | 2 | 0 |
| Reichert, Inc. | 2 | 0 |
| Accutome Ultrasound, Inc. | 1 | 0 |
| American Optical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 1986 | K863200 | COMPUTON(R) Optical Radiation Corp. | HKX |
| Nov 19, 1984 | K843354 | EPISCLERAL VENOUS PRESSURE Eyetech, LLC | HKX |
| Aug 2, 1984 | K841762 | WOODLYN APPLANATION TONOMETER Woodlyn, Inc. | HKX |
| Jun 19, 1984 | K840836 | CAT 100 CooperVision, Inc., GB | HKX |
| Jan 4, 1984 | K833494 | CLERZ LUBRICATING/REWETTING SOLUTION CooperVision, Inc., GB | HKX |
| Apr 9, 1982 | K820751 | GLAUKON Sonometrics Systems, Inc. | HKX |
| Nov 12, 1980 | K802419 | AO NON-CONTACT II TONOMETER American Optical Corp. | HKX |
| Aug 4, 1980 | K801518 | SPAN-AID BRIDGING PILLOW SYSTEM Span-America Medical Systems, Inc. | HKX |
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