Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·ThinPrep Processors and ThinPrep Imaging System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·HIGH FREQUENCY OSCILLATING VENTILATOR

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP IMAGING SYSTEM LABELING

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter with InhibiZone™

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Endoscopic Ablation System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL R Series

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Advia Centaur AFP Immunoassay and Atellica IM AFP Immunoassay

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP(R) PROCESSOR