Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra® System

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent – Microfibrillar Fo

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 3000

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator (WCD) System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·St. Jude Medical Infinity DBS Implantable Pulse Generator

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·DIOMED 630 PDT LASER

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED IMPLANTABLE INFUSION SYSTEM

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PRECISION(TM) UV (VASURFILCON)

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST (WCD 3000S) WEARABLE DEFIBRILLATOR

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·NOVOTTF-100A SYSTEM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·Alair Bronchial Thermoplasty Catheter

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS