17 results · 18ms · Sources: EU EUDAMED, US FDA

Pacemaker/Icd/Crt Non-Implanted Components

FDA classification
FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA classification
FDA Class 3 ·Temporary Non-Roller Type Right Heart Support Blood Pump

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA classification
FDA Class 3 ·Temporary Non-Roller Type Left Heart Support Blood Pump

Femtosecond Laser System For Refractive Correction

FDA classification
FDA Class 3 ·Femtosecond Laser System For Refractive Correction

Computer-Assisted Personalized Sedation System

FDA classification
FDA Class 3 ·Computer-Assisted Personalized Sedation System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification
FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Cultured Human Cell Skin Dressing

FDA classification
FDA Class 3 ·Cultured Human Cell Skin Dressing

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA classification
FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Totally Implanted

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA classification
FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Cap, Cooling (Infants)

FDA classification
FDA Class 3 ·Cap, Cooling (Infants)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA classification
FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Sensor, Glucose, Invasive, Non-Adjunctive

FDA classification
FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA classification
FDA Class 3 ·Sensor, Glucose, Implanted, Non-Adjunctive Use

Barrier, Adhesion, Cardiovascular

FDA classification
FDA Class 3 ·Barrier, Adhesion, Cardiovascular

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA classification
FDA Class 3 ·Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification
FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification
FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit