564 results · 27ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ATS OPEN PIVOT HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve – AP360

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ATS OPEN PIVOT BILEAFLET HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT MECHANICAL HEART VALVES AND OPEN PIVOT AORTIC VALVED GRAFT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-PMMA PCL'S

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Aspiration Therapy System

FDA classification
FDA Class 3 ·Aspiration Therapy System

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