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 ·Activa Deep Brain Stimulation Therapy System

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 and Verify Evaluation System (SNS Bowel)

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON - TB

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·FEMSOFT URETHRAL INSERT

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT & SIZING DEVICE

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·FEMSOFT URETHRAL INSERT

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·FEMSOFT URETHRAL INSERT

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS® Corneal Implants

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD SYSTEM