3,094 results · 19ms · Sources: EU EUDAMED, US FDA

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 530G SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed iPro2 CGM System with Enlite Sensor

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·CONTINUOUS GLUCOSE MONITORING SYSTEM

System, Imaging, Fluorescence

FDA Pre-Market Approval
FDA Class 3 ·XILLIX-LIFE-LUNG

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL MINI SINUS IMPLANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Automated Insulin Dosing , Threshold Suspend

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Cochlear Nucleus CI600 Series Cochlear Implants

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval
FDA Class 3 ·Simplera™ System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® Hybrid™ L24 Cochlear Implant System

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel® Contour Sinus Implant

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus CI624 Implant System

Automated Insulin Dosing Device System, Single Hormonal Control

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

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel and Propel Mini Sinus Implants

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Necleus Auditory Brainstem Impant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·INTRODUCTION CP900 SERIES RECHARGEABLE BATTERIES (A29 AND A30)