14 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
FDA Enforcement
Class II
·Ongoing·Nexstim PLC·June 14, 2017
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
FDA Enforcement
Class I
·Ongoing·NOXBOX LTD·October 15, 2025
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
FDA Enforcement
Class II
·Ongoing·Philips North America, LLC·May 22, 2019
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
FDA Enforcement
Class I
·Ongoing·NOXBOX LTD·October 15, 2025
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature
FDA Enforcement
Class II
·Ongoing·Philips Electronics North America Corporation·August 29, 2018
Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters include: NBP, Sp02, Temperature. The Sure Signs VS2 vital signs monitor is for the monitoring, recording and alarming of multiple parameters of adult, pediatric and neonates in healthcare environments. Additionally, this monitor is intended for transport situations within the healthcare facility.
FDA Enforcement
Class II
·Ongoing·Philips Electronics North America Corporation·August 29, 2018