430 results · 28ms · Sources: EU EUDAMED, US FDA

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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

Lenses, Soft Contact, Extended Wear

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

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval
FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval
FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE

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 Ascending Aortic Prosthesis

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System