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Sign in to claim this brandNIHON KOHDEN AMERICA, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 15353 Barranca Pkwy, Irvine, CA, 92618
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2080783
- DUNS Number
- —
Catalogue (255)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Electroencephalographs Eeg-5208, 5210 | K820066 | FDA 510(k) | Class II | Active |
| Org-7201 Multiparameter Telemetry Monitor | K860239 | FDA 510(k) | Class II | Active |
| Nihon Kohden Ecg-9110k And Ecg-9130k Cardiofax Q And Accessories | K984504 | FDA 510(k) | N/A | Active |
| Mem-4204-4-8, Meb-4204 &4208 Evoke Potent Meas Sys | K912685 | FDA 510(k) | Class II | Active |
| Stress Test System | K810357 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (12)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 18, 2024 | Z-0267-2025 | — | open, classified | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| Sep 18, 2024 | Z-0268-2025 | — | open, classified | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| Apr 29, 2024 | Z-2025-2024 | — | open, classified | Due to software issue the device may give false "SpO2 Probe Failure" alarm |
| Apr 29, 2022 | Z-0314-2025 | — | open, classified | Due to products being shipped/distributed to customers after the products expiration date had past. |
| Jan 8, 2021 | Z-1162-2021 | — | open, classified | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| Dec 21, 2020 | Z-0865-2021 | — | open, classified | Medical device non-conformance to electrical safety standard (IEC 60601-1). |
| Mar 13, 2017 | Z-1768-2017 | — | terminated | The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. |
| Apr 14, 2015 | Z-1543-2015 | — | terminated | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound. |
| Jun 3, 2014 | Z-1979-2014 | — | terminated | Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate. |
| Jan 19, 2012 | Z-0817-2016 | — | terminated | The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow. |
| Aug 23, 2006 | Z-0218-2007 | — | terminated | When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time. |
| Dec 5, 2003 | Z-0506-04 | — | terminated | Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough. |