Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·FAMILY OF MERLIN@HOME TRANSMITTERS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·M6-C Artificial Cervial Disc

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval

FDA Class 3 ·Paradise Ultrasound Renal Denervation System; Paradise Catheter

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Multifocal 3-Piece, TECNIS Foldable Acrylic IOL with OptiEdge

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE (NON-CM) TM POSTERIOR CHAMBER LENSES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ACRYLIC IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS MODEL 305

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS INTRAOCULAR LENS,MODEL AO60 and MI60L

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCADE 6/7f VCS & VASCADE 5F VCS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio; STAR Excimer Laser System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device