2,615 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Multifunctional Ablation Generator (MAG)
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Multifunctional Ablation Generator (MAG)
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ATS AVG (AORTIC VALVED GRAFT)
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·CentriMag Circulatory Support System
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·Synergy Ablation System
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·EPi-Sense Guided Coagulation System
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·Medtronic Open Pivot Aortic Valved Graft (AVG)
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·EPi-Sense®, EPi-Sense ST Guided Coagulation System
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Emblem S-ICD Programmer - Plexus SMT Mfg. Line
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·AtriCure Synergy Ablation System
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·Medtronic Open Pivot Mechanical Valve (OPHV), Medtronic Open Pivot Aortic Valved Graft (AVG)
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Prometra Programmable Infusion Pump System
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ELECSYS FREE PSA
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·Dimension Vista FPSA Flex reagent cartridge (K6452)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ABBOTT AXSYM FREE PSA ASSAY