1,430 results · 19ms · Sources: EU EUDAMED, US FDA

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK BIOPROSTHESIS MODELS 242,342,343C,342R

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·Amplatzer Duct Occluder/Amplatzer Duct Occluder II

Agent, Injectable, Embolic

FDA Pre-Market Approval
FDA Class 3 ·Onyx Liquid Embolic System

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II and Hancock Ultra II Bioprosthesis

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL DEFECT OCCLUDER

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 ANF T510

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic™ Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SILIKON 1000

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·OCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY