7 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
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 Recall
Open, Classified
·Nihon Kohden America Inc·Product code GWQ·December 21, 2020
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 Recall
Open, Classified
·Nihon Kohden America Inc·Product code CCK·April 29, 2022
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
FDA Recall
Open, Classified
·Nihon Kohden America Inc·Product code DQA·September 18, 2024
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
FDA Recall
Open, Classified
·Nihon Kohden America Inc·Product code DQA·September 18, 2024
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
FDA Recall
Open, Classified
·EMD Millipore Corporation·Product code HZT·January 26, 2024
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
FDA Recall
Open, Classified
·Nihon Kohden America Inc·Product code DRG·January 8, 2021
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 Recall
Open, Classified
·Nihon Kohden America Inc·Product code MHX·April 29, 2024