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

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·SOUNDTEC DIRECT SYSTEM

Sensor, Glucose, Invasive

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

Implant, Cochlear

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HiResolution Bionic Ear System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Artificial Pancreas Device System, Threshold Suspend

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT

Implant, Cochlear

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

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·Animas, Vibe System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Hybrid Cochlear Implant

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Propel, Propel mini and Propel Contour Sinus Implants

Automated Insulin Dosing , Threshold Suspend

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

Automated Insulin Dosing Device System, Single Hormonal Control

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·iPro2 System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Implant, Cochlear

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Cochlear™ Nucleus® CI632 cochlear implant with Slim Modiolar electrode, Cochlear™ Nucleus® CI532 cochlear implant with S

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL, PROPEL MINI and PROPEL CONTOUR

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COCHLEAR IMPLANT