Nihon Kohden Corporation - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
Nihon Kohden Corporation has 18 FDA 510(k) cleared medical devices. Based in Tokyo, JP.
Latest FDA clearance: Oct 2025. Active since 2015.
Browse the FDA 510(k) cleared devices submitted by Nihon Kohden Corporation Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Nihon Kohden America, Inc., Nihon Kohden America and Nihon Kohden America, LLC.
18 devices
Cleared
Oct 09, 2025
EEG-1260A Neurofax System (EEG-1260A)
Neurology
161d
Cleared
Jun 10, 2025
TG-980P CO2 Sensor Kit (TG-980P)
Anesthesiology
169d
Cleared
Jul 31, 2023
CNS-2101 Central Monitor
Cardiovascular
244d
Cleared
Jul 21, 2022
Life Scope PT BSM-1700 Series Bedside Monitor
Anesthesiology
108d
Cleared
Dec 29, 2021
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE...
Anesthesiology
86d
Cleared
Jul 16, 2021
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope...
Cardiovascular
235d
Cleared
May 02, 2021
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life...
Anesthesiology
293d
Cleared
Feb 07, 2020
Elefix V Paste for EEG & EMG
Neurology
198d
Cleared
May 28, 2019
Nihon Kohden SVM-7200 Series Vital Signs Monitor
Cardiovascular
91d
Cleared
Mar 19, 2019
AE-120A EEG Head Set
Neurology
90d
Cleared
Oct 11, 2017
Nihon Kohden CO2 Monitor
Anesthesiology
119d
Cleared
Aug 25, 2017
Nihon Kohden Wireless Input Unit WEE-1200
Neurology
130d
Cleared
May 19, 2017
Nihon Kohden QP-160AK EEG Trend Program
Neurology
147d
Cleared
Apr 04, 2017
Nihon Kohden Vital Sign Telemeter
Cardiovascular
116d
Cleared
Feb 24, 2017
TG-970P CO2 Sensor Kit
Anesthesiology
233d
Cleared
Sep 02, 2016
Nihon Kohden Vital Sign Telemeter
Cardiovascular
254d
Cleared
Apr 08, 2016
Nihon Kohden Afib Detection Program QP-039P
Cardiovascular
238d
Cleared
Apr 24, 2015
Neuromaster G1 MEE200
Neurology
220d