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Specular Microscope
TOMEY CORPORATION. · Model EM-4000 · UDI-DI 04582273612822
NQE
Prescription
9
510(k) clearances
0
Adverse events
2
Recalls
10
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-02-25 | Nidek, Inc. | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) |
| 2016-08-08 | Nidek Inc | Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA. |
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