135 results · 18ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

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 (RF452)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Epic Plus, Epic Max Tissue Heart Valves

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Epic™ Plus Tissue Heart Valves, Epic™ Max Tissue Heart Valves, Epic™ Tissue Heart Valves

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Epic™ Max Tissue Heart Valves

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Freezor Max Cardiac Cryoablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOBLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Freezor MAX Cardiac Cryoablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PULSAR/PULSAR MAX/ DISCOVERY/MERIDIAN

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Artic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Freezor TM Cardiac Cryoablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·FREEZOR MAX CARDIAC CRYO ABLATION CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·9F Freezor MAX Cardiac Cryoablation Catheter

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON - TB

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter