Home › Device types › NQE
Microscope, Specular
FDA product code NQE · Class 2 · Ophthalmic
12
Registered devices
0
Adverse events
2
Recalls
9
510(k) clearances
Devices with this code
NA — KONAN MEDICAL, INC.Specular Microscope — TOMEY CORPORATION.NA — KONAN MEDICAL, INC.EB-3000xyz — Hightech American Industrial Labs IncHAI CL-1000xyz clinical specular microscope — Hightech American Industrial Labs IncEB-2000xyz — Hightech American Industrial Labs IncNA — KONAN MEDICAL, INC.SPECULAR MICROSCOPE — NIDEK CO.,LTD.SPECULAR MICROSCOPE — TOMEY CORPORATION.NA — KONAN MEDICAL, INC.NA — KONAN MEDICAL, INC.SPECULAR MICROSCOPE SP-1P — TOPCON CORPORATION
Recent 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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