83 results · 17ms · Sources: EU EUDAMED, US FDA

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer PFO Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Talisman™ PFO Occluder

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Patent Foramen Ovale (PFO) Occluder

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 530G Insulin Pump

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm real time Insulin Pump / Paradigm Real time revel Insulin Pump

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Paradigm Real Time Revel Insulin Pump

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER AND PFO OCCLUDER AMPLATZER 45 DEGREE DELIVERY AND EXANGE SYSTEMS

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER® Smart System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart Mini IPG

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·Optimizer Smart System and Optimizer Smart Mini System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIhome Remote Patient Monitoring System

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart IPG