14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
FDA 510(k)
FDA Class 1
·General Hospital
ADMIRA FLOW
FDA 510(k)
FDA Class 2
·Dental
LUNAR REPORT GENERATOR II
FDA 510(k)
FDA Class 2
·Radiology
SMARTMONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 16, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 18, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·June 13, 2008
SMARTMONITOR 2 PROFESSIONAL SERIES
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013
DIMENSION VISTA®
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015