560 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·BIO-RAD MONOLISA ANTI-HBC IGM EIA
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Powerheart® G3, G3 Plus and G5 AEDs
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval Sutureless Heart Valve
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·PERCEVAL SUTURELESS HEART VALVE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
Immunohistochemistry Antibody Assay, C-Kit
FDA Pre-Market Approval
FDA Class 3
·DAKO C-KIT PHARMDX
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval S Sutureless Heart Valve; Perceval Plus Sutureless Heart Valve
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·Carbomedics Prosthetic Heart Valve (CPHV)
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·PERCEVAL PLUS SUTURELESS HEART VALVE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval Sutureless Heart Valve, Perceval PLUS
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·PERCEVAL SUTURELESS HEART VALVE
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Perceval Sutureless Heart Valve