Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·Esteem

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System

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

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CLOSER/CLOSER S SMC 6 FRENCH SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYLAFORM (HYLAN B GEL); PREVELLE SILK

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL LEAK SEALANT

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System