7,890 results · 51ms · 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