Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Surpass Streamline Flow Diverter

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MarginProbe System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 System

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

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS(R) TOTAL KNEE SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX CERAMIC HIP SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND II SYSTEM