10 results
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27ms
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Sources: EU EUDAMED, US FDA
MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SureSigns VSi
FDA UDI
Philips Medical Systems Hsg·00884838028364·SureSigns VSi - NBP
KPP PERITONEAL DIALYSATE FILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)
FDA 510(k)
FDA Class 2
·Orthopedic
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·November 1, 2012
ICHEM VELOCITY STRIP
FDA Adverse Event
Malfunction
·IRIS INTERNATIONAL·Product code KQO·June 18, 2015
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
FDA Enforcement
Class III
·Terminated·Philips Electronics North America Corporation·December 27, 2017
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. 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. The SureSigns VSi vital signs monitor is for measurement 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.·September 5, 2012
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. 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. The SureSigns VSi vital signs monitor is for measurement 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 Recall
Terminated
·Philips Healthcare Inc.·Product code DXN·August 15, 2012