2,061 results · 21ms · Sources: EU EUDAMED, US FDA

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, Juvéderm Ultra Plus XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Voluma XC, Juvéderm Vollure XC, Juvederm Volbella XC

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·SUPERION INTERSPINOUS SPACER

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 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)

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™);RHYTHMIA HDx™

Implant, Cochlear

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

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

FDA Pre-Market Approval
FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ OI

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

Ventilator, High Frequency

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

Cardiac Ablation Percutaneous Catheter

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

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

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 ·Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP