8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COOK-VPI INTERMITTENT CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
6200 Ultrasound System and 6250 Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ADHESIVE PERISTOMAL COVERING W/WO CONN.
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SECURA VR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·June 10, 2014
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DSI·October 9, 2010
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·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