7,890 results
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51ms
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Sources: EU EUDAMED, US FDA
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·Amplatzer Duct Occluder/Amplatzer Duct Occluder II
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER SEPTAL OCCLUDER
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER SEPTAL DEFECT OCCLUDER
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE
Alternate Controller Enabled Insulin Infusion Pump
FDA classification
FDA Class 2
·Alternate Controller Enabled Insulin Infusion Pump
Bag, Ice
FDA classification
FDA Class 1
·Bag, Ice
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE)
DRY LASER IMAGER, MODEL DRYPRO MODEL 793
FDA 510(k)
FDA Class 2
·Radiology
20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
FDA 510(k)
FDA Class 2
·Radiology
DIRECT DIGITIZER, REGIUS MODEL 190
FDA 510(k)
FDA Class 2
·Radiology
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
FDA classification
FDA Class 1
·Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EPICARDIAL TRANSVENE LEAD, CABLE HEADER, ACE HEADER, UPSIZING SLEEVE FOR HV LEAD DF-1, UPSIZING SLEEVE, END CAP
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EPICARDIAL TRANSVENE/CABLE/ACE HEADER/UPSIZING SLEEVE FOR HV LEAD DF-1/UPSIZING SLEEVE/LEAD END PIN CAP
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AFP RIA KIT
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·Alere NMP22 BladderChek Test
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·Alere NMP22 BladderChek Test
System, Test, Tumor Marker, For Detection Of Bladder Cancer
FDA Pre-Market Approval
FDA Class 3
·NMP22 ELISA TEST KIT