6,013 results · 23ms · Sources: EU EUDAMED, US FDA

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP NT CLIP DELIVERY SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC -L TOTAL DISC REPLACEMENT DEVICE

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BIODIVYSIOI AS PC (PHOSPHORYLCHOLINE) COATED STENT AND DELIVERY SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILZONE

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform”

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·Titan Inflatable Penile Prosthesis

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETER

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·CraniSeal Dural Sealant

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip G5 System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·SJM EPIC VALVE AND SJM EPIC SUPRA VALVE

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC-L TOTAL DISC REPLACEMENT