410 results · 20ms · Sources: EU EUDAMED, US FDA

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·TMR2000 HOLMIUM LASER SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH 3.5F SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE 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

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

System, Hemodynamic, Implantable

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

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

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 SCI reusable instrumentation

Lenses, Soft Contact, Extended Wear

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

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH 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