Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTION ctDx FIRST

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Onyx Liquid Embolic System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Surpass Streamline Flow Diverter

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation Therapy System for Parkinson's Disease

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Sysstems and Piseces, Specify and Vectris Spinal Cord Stimu

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X 8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY, SCS SCREENING TRAIL

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG Systems

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spiral Cord Stimulation (SCS) System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type-1 System

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Optune Gio