19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
GD
FDA UDI
General Devices·00862186000386·The Rosetta-Lt Data Translator receives and com...
AUDIOSCREENER OAE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CHESS HAND SURGERY SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016
ACL TOP
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005
ACL TOP
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016
ACL ADVANCE
FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 8, 2013
POLAR CARE 500
FDA Adverse Event
Other
·BREG, INC·Product code ILO·March 24, 2011
`TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·May 8, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 16, 2017
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·September 12, 2016
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018