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

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”)

Bronchial Thermoplasty System

FDA Pre-Market Approval
FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Bronchial Thermoplasty System

FDA Pre-Market Approval
FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·ExAblate 4000 System (Exablate Neuro or the system)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate 4000 System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate 4000 (“Neuro”) Type 1.0 & 1.1

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

Bronchial Thermoplasty System

FDA Pre-Market Approval
FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE

Bronchial Thermoplasty System

FDA Pre-Market Approval
FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro)

Bronchial Thermoplasty System

FDA Pre-Market Approval
FDA Class 3 ·Alair Bronchial Thermoplasty Catheter

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)