469 results · 19ms · Sources: EU EUDAMED, US FDA

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

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BioGlue Surgical Adhesive

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF (Heart Failure) System

Intravascular Radiation Delivery System

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)

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

System, Hemodynamic, Implantable

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

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·Novoste™ Beta-Cath™ System

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·HEALTHTRONICS OSSATRON

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 ·BETA-CATH (TM) SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS I3 Patient Electronics System (PES)

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BioGlue® Surgical Adhesive

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·ECLIPSE TMR HOLMIUN LASER SYSTEM

System, Hemodynamic, Implantable

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CUSTOMEYES(TM) 45L&55L (BUFILCON A)