Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON SENOFILCON A BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

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

FDA Pre-Market Approval

FDA Class 3 ·Attune Primary System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH (TM) SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS Hospital System, model CM3100

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

System, Identification, Contact Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTMARK

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BioGlue Surgical Adhesive

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON