6,013 results · 21ms · Sources: EU EUDAMED, US FDA

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