Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS Accessories DBS Extensions DBS Leads DBS Neurostimulators 37022 DBS Neurostimulators 37601,37602,37603,DBS Programmi

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS ACCESSORIES,DBS EXTENSIONS,DBS LEADS,DBS NEUROSTIMULATORS IMPLANTABLE,DBS NEUROSTIMULATORS SOLETRA FAMILY

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS EXTENSIONS, DBS LEADS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS EXTENSIONS, DBS LEADS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS LEAD, DBS LEAD-REDUCED SPACING

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus™ DBS Systems, Vercise Gevia™ DBS System, Vercise™ PC DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY, DBS ACCESSORIES, DBS INS SOLETRA FAMILY & DBS INS KINETRA FAMILY

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise DBS System / Vercise PC DBS System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS Neurostimulators External, DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Activa F

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System (Bowel)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel and Synergy Spinal Cord Stimulation Systems, Intellis Implantable Neurostimulation System and Pisc