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

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FLUOROCON TM-60

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 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·CARDIOGENESIS HOLMIUM TMR SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER 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 ·WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·TEGRESS URETHRAL IMPLANT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)