Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Protégé RX Carotid Stent System; Protégé GPS Self-Expanding Peripheral Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex Self-Expanding Peripheral Stent System

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·VenaSeal Closure System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGER

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGER

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U Blue Light Photodynamic Therapy Illuminator

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPHY ILLUMINATOR

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·SENSITITRE