Panels › Ophthalmic › Product code NQE · Class 2
Microscope, Specular
Regulation 886.1850
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NQE
| Company | 510(k)s | Recalls |
|---|---|---|
| Nidek Co., Ltd. | 3 | 2 |
| Konan Medical, Inc. | 4 | 0 |
| Tomey Corporation | 1 | 0 |
| Topcon Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2020 | K191558 | Konan Specular Microscope XVII Konan Medical, Inc., JP | NQE |
| Mar 14, 2018 | K173980 | Specular Microscope CEM-530 Nidek Co., Ltd., JP | NQE |
| Jan 19, 2018 | K171313 | EM-4000 Specular Microscope Tomey Corporation, JP | NQE |
| Mar 17, 2016 | K151706 | Specular Microscope CEM- 530 Nidek Co., Ltd., JP | NQE |
| May 29, 2015 | K142417 | SP-1PSpecular Microscope Topcon Corporation, JP | NQE |
| Nov 27, 2013 | K130565 | SPECULAR MICROSCOPE CEM-530 Nidek Co., Ltd. | NQE |
| Apr 11, 2012 | K120264 | KONAN SPECULAR MICROSCOPE XIV Konan Medical, Inc. | NQE |
| Feb 22, 2008 | K062763 | NONCON ROBO PACHY F&A Konan Medical, Inc. | NQE |
| Mar 19, 2004 | K040373 | KERATO ANALYZER (EKA) Konan Medical, Inc. | NQE |
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