469 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·NOVOSTE BETA-CATH SYSTEM
Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
FDA Pre-Market Approval
FDA Class 3
·Cartiva Synthetic Cartilage Implant (Cartiva SCI)
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
Glue, Surgical, Arteries
FDA Pre-Market Approval
FDA Class 3
·BIOGLUE SURGICAL ADHESIVE
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·CARDIOGENESIS TMR SYSTEM
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·CardioGenesis TMR System
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CardioMEMS HF System
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CardioMEMS HF System
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·8IGNATURE CONTACT LENS
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·CARDIOGENESIS TMR LASER SYSTEM
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·TMR HOLMIUM LASER 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
System, Identification, Contact Lens
FDA Pre-Market Approval
FDA Class 3
·SOFTMARK
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·TMR HOLMIUM LASER SYSTEM
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·CardioGenesis TMR System
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·On-X Prosthetic Heart Valve and Ascending Aortic Prothesis
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis devices