8 results
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19ms
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Sources: EU EUDAMED, US FDA
4-WIRE (CARSON) STONE EXTRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
40-42mm BiPolar Head and 22mm Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
AEQUALIS SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·June 10, 2014
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 10, 2012
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
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 Recall
Open, Classified
·Philips Electronics North America Corporation·Product code MHX·July 13, 2018