17 results
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48ms
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Sources: EU EUDAMED, US FDA
Nasal Alar Sp02 Sensor
FDA UDI
XHALE ASSURANCE, INC.·B21303030·The Assurance® Nasal Alar SpO2™ Sensor is indi...
Nasal Alar Sp02 Sensor
FDA UDI
XHALE ASSURANCE, INC.·B2130201A010·The Assurance® Nasal Alar SpO2™ Sensor is indi...
Nasal Alar Sp02 Sensor
FDA UDI
XHALE ASSURANCE, INC.·B213301112140·The Assurance® Nasal Alar SpO2™ Sensor is indi...
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Malfunction
·XHALE ASSURANCE, INC·Product code DQA·November 6, 2017
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·April 14, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·April 14, 2019
NASAL ALAR SP02 SENSOR
FDA Adverse Event
Malfunction
·XHALE ASSURANCE, INC.·Product code DQA·February 20, 2020
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 8, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 8, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 9, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 9, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 9, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 9, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 9, 2019
NASAL ALAR SPO2 SENSOR
FDA Adverse Event
Injury
·XHALE ASSURANCE, INC·Product code DQA·July 9, 2019
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision
FDA Recall
Terminated
·Xhale Assurance, Inc.·Product code DQA·May 8, 2019
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision
FDA Enforcement
Class II
·Terminated·Xhale Assurance, Inc.·August 7, 2019