9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDICINAL LEECHES
FDA 510(k)
FDA Unclassified
·Unknown
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496040187·MISS RELAX MICRO RETE 70 SHEER, SIZE S, NERO, G...
REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
KIMAX, MODEL 1024
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code KWA·April 8, 2013
OLYMPUS EVIS EXERA COLONOVIDEOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code FDF·March 24, 2011
ZIPWIRE HYDROPHILIC GUIDE WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQX·May 8, 2008
ADVIA CENTAUR XP CEA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code DHX·June 28, 2019
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