System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·PEARL 8.0 HANDPIECE

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·TMR Holmium Laser System

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·TMR HOLMIUM LASER SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X ASCENDING AORTIC PROSTHESIS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA-CATH 3.5F SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cardiomems HF Pressure Measurement System

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·Cartiva Synthetic Cartilage Implant (Cartiva SCI)

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA-CATH 3.5 SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE