10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
FDA Enforcement
Class II
·Ongoing·Nihon Kohden America Inc·November 6, 2024
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
FDA Enforcement
Class II
·Ongoing·Nihon Kohden America Inc·November 6, 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.
FDA Enforcement
Class II
·Ongoing·Nihon Kohden America Inc·June 12, 2024
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·July 9, 2014
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
FDA Enforcement
Class II
·Ongoing·Nihon Kohden America Inc·March 10, 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.
FDA Enforcement
Class II
·Ongoing·Nihon Kohden America Inc·February 3, 2021
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·February 24, 2016
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.
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·May 6, 2015
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).
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·April 19, 2017
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.
FDA Enforcement
Class II
·Ongoing·Nihon Kohden America Inc·November 13, 2024