364 results · 41ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Durata and Optisure

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

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav Open Irrigated Ablation Catheter

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·Versant HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER NAV AND EZ STEER NAV DS CATHETERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER NAV

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV

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

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER™DS, EZ STEER™NAV, EZ STEER™, EZ STEER™THERMOCOOL NAV

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER THERMOCOOL NAV

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER THERMOCOOL NAV

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

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER NAV DS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·NAV 2 Quadpole LV Straight 86CM 4671, NAV 2 Quadpole LV Straight 95CM 4672, NAV 2 Quadpole LV Short Spiral 86CM 4674, N

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER