FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

175 results for "Nihon Kohden America, Inc."
1–24 of 175
Search insights Median review: 101d Cleared: 100% Top manufacturer: Nihon Kohden America, Inc. Lead specialty: Cardiovascular
Cleared Dec 29, 2021
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE...
K213316 · KOI
Nihon Kohden Corporation
Anesthesiology · 86d
Cleared May 02, 2021
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life...
K201949 · KOI
Nihon Kohden Corporation
Anesthesiology · 293d
Cleared Oct 11, 2017
Nihon Kohden CO2 Monitor
K171765 · CCK
Nihon Kohden Corporation
Anesthesiology · 119d
Cleared Aug 25, 2017
Nihon Kohden Wireless Input Unit WEE-1200
K171124 · GWQ
Nihon Kohden Corporation
Neurology · 130d
Cleared May 19, 2017
Nihon Kohden QP-160AK EEG Trend Program
K163644 · OMA
Nihon Kohden Corporation
Neurology · 147d
Cleared Apr 04, 2017
Nihon Kohden Vital Sign Telemeter
K163459 · MHX
Nihon Kohden Corporation
Cardiovascular · 116d
Cleared Feb 24, 2017
TG-970P CO2 Sensor Kit
K161860 · CCK
Nihon Kohden Corporation
Anesthesiology · 233d
Cleared Sep 02, 2016
Nihon Kohden Vital Sign Telemeter
K153707 · MHX
Nihon Kohden Corporation
Cardiovascular · 254d
Cleared Apr 08, 2016
Nihon Kohden Afib Detection Program QP-039P
K152305 · DSI
Nihon Kohden Corporation
Cardiovascular · 238d
Cleared Mar 22, 2012
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
K113117 · GWQ
Nihon Kohden America, Inc.
Neurology · 153d
Cleared Mar 16, 2012
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND...
K120485 · OMA
Nihon Kohden America, Inc.
Neurology · 28d
Cleared Jul 09, 2010
NIHON KOHDEN QP-160AK EEG TREND PROGRAM
K092573 · OMA
Nihon Kohden America, Inc.
Neurology · 323d
Cleared Mar 02, 2009
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
K083456 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 101d
Cleared Dec 24, 2008
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001...
K083271 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 48d
Cleared Nov 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
K082785 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 64d
Cleared Oct 06, 2008
SEN-4100 ELECTRIC STIMULATOR
K071969 · GWF
Nihon Kohden America, Inc.
Neurology · 447d
Cleared Aug 29, 2008
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
K080546 · OLT
Nihon Kohden America, Inc.
Neurology · 183d
Cleared Mar 28, 2008
PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
K073550 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 101d
Cleared Feb 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
K080342 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 18d
Cleared Jan 11, 2008
EEG-1100A SWITCH BOX
K073491 · OLV
Nihon Kohden America, Inc.
Neurology · 30d
Cleared Nov 29, 2007
YG-125T AND YG-135T NASAL ADAPTER
K072843 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 56d
Cleared Aug 30, 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 21d
Cleared Aug 17, 2007
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
K072060 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 21d
Cleared Jun 29, 2007
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
K071058 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 74d