294 results · 27ms · 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 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 Model 4000 Type 1.0 and 1.1 Systems

Mr-Guided Focused Ultrasound System

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

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS

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

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 (Exablate Neuro)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 400 Type 1.0 & Type 1.1 (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 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate

Mr-Guided Focused Ultrasound System

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

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A

Mr-Guided Focused Ultrasound System

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

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL)

Bronchial Thermoplasty System

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

Bronchial Thermoplasty System

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