Nihon Kohden America, Inc.
Nihon Kohden America, Inc. holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2012, with 10 FDA device recalls on record.
Top product codes for Nihon Kohden America, Inc.
FDA recalls by Nihon Kohden America, Inc.
- Z-0267-2025 — Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
- Z-0268-2025 — Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
- Z-2025-2024 — BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility.
- Z-0314-2025 — Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
- Z-1162-2021 — WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
- Z-0865-2021 — PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
- Z-1768-2017 — Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
- Z-1543-2015 — Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected.
- Z-1979-2014 — CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
- Z-0817-2016 — MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nihon Kohden America, Inc.
1–100 of 166- K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
- K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
- K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM
- K083456 — NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
- K083271 — BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
- K082785 — NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES
- K071969 — SEN-4100 ELECTRIC STIMULATOR
- K080546 — NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A
- K073550 — PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
- K080342 — NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
- K073491 — EEG-1100A SWITCH BOX
- K072843 — YG-125T AND YG-135T NASAL ADAPTER
- K072217 — ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
- K072060 — QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
- K071058 — MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
- K062115 — CARBON DIOXIDE MONITOR, MODEL OLG-2800A
- K052511 — CARDIOFAX CE, MODEL ECG-1500 A
- K051178 — MEE-1000A NEUROMASTER
- K050833 — ELECTRODE JUNCTION BOX, MODEL JE-921A
- K043517 — TRANSMITTER, ZS-940PA SERIES
- K042827 — CARDIOFAX CE, MODEL PEA-1110K
- K040875 — CAP-ONE, MODEL TG-920P
- K040395 — CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
- K033475 — WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
- K032749 — BEDSIDE MONITOR, MODEL OPV-1500
- K030105 — ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A
- K023475 — CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
- K022121 — PSG INPUT BOX, MODEL JE-912AK
- K020046 — MULTIGAS UNIT, MODEL AG-920RA
- K011918 — NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
- K010590 — NEUROPACK MICRO, MODEL MED-9100A SERIES
- K011204 — NEUROFAX, MODELS EEG-1100A, EEG-9100A
- K002068 — ORG-9200A
- K002473 — WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
- K001433 — CNS-9300 SERIES CENTRAL STATION
- K001693 — LIFE SCOPE P, MODEL BSM-4100 SERIES
- K000517 — LIFE SCOPE EC, MODEL BSM-1102
- K000338 — VITAPORT 3
- K992455 — NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
- K992742 — NEUROFAX, MODEL EEG-1100A
- K991899 — NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
- K990063 — NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
- K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
- K984504 — NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
- K983072 — AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
- K974292 — NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
- K973918 — NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
- K971436 — NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
- K972310 — NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
- K971355 — NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
- K971194 — NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
- K964305 — NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
- K961272 — NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
- K945944 — NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
- K946175 — NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
- K945578 — NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
- K935877 — NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
- K944422 — BSM-8800A BEDSIDE MONITOR
- K944678 — NIHON KOHDEN ELECTROENCEPHALOGRAPH
- K950208 — NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
- K944027 — AG-839PA CO2 MODULE AND ACCESSORIES
- K922394 — CARDIOFAX Q ECG-8420A
- K920154 — BSM-8800A BEDSIDE MONITOR
- K920743 — DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
- K914092 — BSM-2100A CONFIGURED PATIENT MONITOR
- K913117 — ZB-860PA MULTIPARAMETER TRANSMITTER
- K915096 — NEUROFAX EEG 5532
- K912685 — MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
- K912744 — ORG-8200A UNIVERSAL SIGNAL HOUSING
- K914971 — TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
- K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
- K910629 — AP-860PA NIBP MODULE
- K902550 — EEG-5400 SERIES
- K904696 — WEP-8430A TELEMETRY CENTRAL STATION
- K904758 — CARDIOFAX ECG-8830A
- K890736 — TFV-2300 INFUSION PUMP
- K901034 — MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
- K896359 — AG-820PA FI02 MODULE
- K900272 — NKA MODELS AB-601G AND AB-621G
- K894631 — NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
- K894691 — MODEL AO-800PA CO2 MODULE
- K894492 — NKA MODEL SEC-3102 CARDIAC STIMULATOR
- K891486 — AR-800PA RESPIRATION MODULE
- K894692 — BEDSIDE MONITORS, BSM-8301A, BSM-8302A
- K894693 — AP-851PA NIBP MODULE
- K890274 — MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR
- K884050 — CNS-8200A CENTRAL NURSES STATION
- K884536 — AL-800PA PULSE OXIMETER MODULE
- K884537 — AE-800PA EEG MODULE
- K882254 — OEC-7102 ECG/NIBP MONITOR
- K883973 — MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
- K881307 — OLV 1100; OLV 1200 PULSE OXIMETERS
- K881177 — MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
- K880575 — CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
- K881831 — WS 800R THERMAL ARRAY RECORDER
- K874796 — MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
- K873874 — CARDIOFAX-V ECG-8110A
- K870794 — MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER
- K872241 — LIFESCOPE 12, BSM 8500A PATIENT MONITOR
- K870795 — EMG ELECTRODES AND EXTENSION CORDS
Data sourced from openFDA. This site is unofficial and independent of the FDA.