10,000 results · 46ms · Sources: EU EUDAMED, US FDA

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type-1 System

System, Identification, Contact Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTMARK

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 Neuro Thalamotomy

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 4000 System Type-1 (i.e. 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 NEURO THALAMOTOMY

Mr-Guided Focused Ultrasound System

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

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”)

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)

System, Identification, Contact Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTMARK