374 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·VERIFLEX CORONARY STENT SYSTEM
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HeartMate 3 Left Ventricular Assist System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 Ultra Transcatheter Heart Valve System (THV)
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·FLOSEAL (R) MATRIX HEMOSTATIC SEALANT AND PROCEED (TM) HEMOSTATIC SEALANT
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·XACT CAROTID STENT SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·Bellafill Dermal Filler
Agent, Occluding, Vascular, Permanent
FDA Pre-Market Approval
FDA Class 3
·VENASEAL CLOSURE SYSTEM
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
Fluid, Intraocular
FDA Pre-Market Approval
FDA Class 3
·ADATO Sil-Ol 5000 Silicone Oil
Barrier, Absorbable, Adhesion
FDA Pre-Market Approval
FDA Class 3
·GYNECARE INTERCEED Absorbable Adhesion Barrier
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·NOVOSTE (TM) BETA-CATH(TM) SYSTEM
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·CapSure Epicardial Pacing Lead
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR AND AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·EDWARDS INTUITY Elite Valve
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Magna Ease® Pericardial Aortic Bioprosthesis with ThermaFix tissue process
Heart-Valve, Non-Allograft Tissue
FDA Pre-Market Approval
FDA Class 3
·Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis