506 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
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
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
·NOVOSTE BETA-CATH 3.5 FR SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
System, Laser, Transmyocardial Revascularization
FDA Pre-Market Approval
FDA Class 3
·TMR Holmium Laser System
Glue, Surgical, Arteries
FDA Pre-Market Approval
FDA Class 3
·BIOGLUE SURGICAL ADHESIVE
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ON-X PROSTHESTIC HEART VALVE
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARDIOMEMS HF PRESSURE MEASUREMENT 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
Glue, Surgical, Arteries
FDA Pre-Market Approval
FDA Class 3
·CRYOLIFE BIOGLUE SURGICAL ADHESIVE
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
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·NOVOSTE BETA-CATH SYSTEM
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·BETA-CATH 3.5F SYSTEM - 60 MM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·CUSTOMEYES 70L & 79L (LIDOFILCON A&B)