Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS Extensions

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

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, RESUME, SPECIFY & VECTRIS SPINAL CORD STIMULATION

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILLIC) CONTACT LENSES

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor System

IMPLANTABLE PULSE DEVICES

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

FDA 510(k)

FDA Class 3 ·Cardiovascular

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS MODEL 4001

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5866-24 PACEMAKER LEAD ADAPTOR

FDA 510(k)

FDA Class 3 ·Cardiovascular