Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Drug Delivery Infusion Pumps SynchroMed

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANIAL HELMET

FDA 510(k)

FDA Class 2 ·Neurology

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LARIAT PALATE EXPANDER

FDA 510(k)

FDA Class 1 ·Dental

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOBRA GPS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MYOSYSTEM WITH CUSTOMIZING

FDA 510(k)

FDA Class 2 ·Neurology

START JUNIOR

FDA 510(k)

FDA Class 1 ·Physical Medicine

PERIMETRICS PERIOMETER

FDA 510(k)

FDA Class 1 ·Dental

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

FDA 510(k)

FDA Class 2 ·Cardiovascular