Nihon Kohden Corporation is one of 135 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.
Nihon Kohden Corporation - FDA 510(k) Cleared Devices
Recent clearances: GF-310R Multigas Unit (GF-310R), YP-710T Series NIBP Cuff, EEG-1260A Neurofax System (EEG-1260A)
20
Total
20
Cleared
0
Denied
Nihon Kohden Corporation has 20 FDA 510(k) cleared medical devices. Based in Tokyo, JP.
Latest FDA clearance: Aug 2026. 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, LLC and NJK & Associates, Inc..
FDA 510(k) Regulatory Record - Nihon Kohden Corporation
20 devices
Cleared
Aug 12, 2026
GF-310R Multigas Unit (GF-310R)
Anesthesiology
440d
Cleared
May 06, 2026
YP-710T Series NIBP Cuff
Cardiovascular
61d
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