21 results · 26ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta™ Valve with Glide Technology™

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ELCA Coronary Atherectomy Catheters

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Portico™

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Leadless Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Micra VR/AV Application

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Platform, CareLink SmartSync Host Application, CareLink SmartSync Common Application, CareLink SmartS

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

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Myopore® Sutureless Myocardial Pacing Lead

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Brio Neurostimulation System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Axium Neurostimulator System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Genesis Neurostimulation System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Deep Brain Stimulation Therapy System for Parkinson's Disease

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Spinal Cord Stimulation (SCS) System