2,615 results · 19ms · Sources: EU EUDAMED, US FDA

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