2,109 results · 25ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CPI SWITCH BOX

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

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav XP, Nav MiFi XP

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

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav Ol

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

FDA Pre-Market Approval
FDA Class 3 ·Freezer MAX

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

FDA Pre-Market Approval
FDA Class 3 ·Freezor MAX

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

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

FDA Pre-Market Approval
FDA Class 3 ·DiamondTemp Ablation System

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LifePulse High Frequency Ventilator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ETI-MAX 3000 ANALYZER

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS Total Knee System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS

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

FDA Pre-Market Approval
FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

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