6,013 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER MUSCULAR VSD OCCLUDER
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER DUCT OCCLUDER
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·Amplatzer Patent FOramen Ovale Occluder
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·ZYPLAST(R) COLLAGEN IMPLANT
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·BILEAFLET-CENTER OPENING CARDIAC VALVE
Occluder, Patent Ductus, Arteriosus
FDA Pre-Market Approval
FDA Class 3
·AMPLATZER DUCT OCCLUDER, AMPLATZER DUCT OCCLUDER II,
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·BIODIVYSIO AS OTW
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MitraClip System (NTR and XTR)
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTERS MECHANICAL HEART VALVE
Device, Impotence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·Titan Inflatable Penile Prosthesis (IPP)
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MITRACLIP CLIP DELIVERY SYSTEM
Paste, Injectable For Vocal Cord Augmentation
FDA Pre-Market Approval
FDA Class 3
·POLYTEF PASTE FOR VOCAL CORD INJECTION
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·prodisc® C
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Zoll X Series Device (Oridion MicroMediCO2)
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·MASTERS VALVED GRAFT WITH HEMASHIELD GRAFT TECHNOLOGY
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM