9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PREGNANCY-SKREEN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Full Wedge Lateralized and Augmented Baseplates
FDA UDI
FX SOLUTIONS·03701037319048·HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEP...
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·April 8, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 12, 2011
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES, INC.·Product code MIH·May 22, 2008
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