115 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 System (“Exablate Neuro”)

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist

Mr-Guided Focused Ultrasound System

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

Temporary Non-Roller Type Right Heart Support Blood Pump

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

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP Flex with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Mr-Guided Focused Ultrasound System

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

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP Flex with SmartAssist

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·ExAblate

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval
FDA Class 3 ·Exablate 4000 (Exablate Neuro)