29 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
FDA Enforcement
Class II
·Terminated·Suntech Medical, Inc.·January 22, 2020
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
Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
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
Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
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
Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
FDA Enforcement
Class I
·Terminated·Richard-Allan Scientific Company·October 15, 2014
Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·February 20, 2013
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
FDA Enforcement
Class I
·Ongoing·NOXBOX LTD·October 15, 2025
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·October 29, 2014