232 results · 21ms · Sources: EU EUDAMED, US FDA

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace® RNS® System

Aspiration Therapy System

FDA classification
FDA Class 3 ·Aspiration Therapy System

Atrial Defibrillator

FDA classification
FDA Class 3 ·Atrial Defibrillator

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification
FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

FDA classification
FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

FDA classification
FDA Class 3 ·Whole Blood Pre-Treatment T-Cell Enrichment Reagent

Diagnostic Low Electric Field

FDA classification
FDA Class 3 ·Diagnostic Low Electric Field

Test, Urea Adult And Pediatric (Breath),

FDA classification
FDA Class 3 ·Test, Urea Adult And Pediatric (Breath),

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification
FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Hepatitis Viral B Dna Detection

FDA classification
FDA Class 3 ·Hepatitis Viral B Dna Detection

Nitric Oxide Generator And Delivery System

FDA classification
FDA Class 3 ·Nitric Oxide Generator And Delivery System

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

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