10,000 results · 51ms · Sources: EU EUDAMED, US FDA

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·THERAKOS® CELLEX® Photopheresis System Procedural Kit

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·BIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·CORDIS PALMAZ(R) BALLOON-EXPANDABLE STENT

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·SEPRAFILM BIORESORBABLE MEMBRANE

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval
FDA Class 3 ·Vivistim® System

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

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

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval
FDA Class 3 ·PROGENSA PCA3 ASSAY

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ACS MULTI-LINK CORONARY STENT SYSTEMS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ActaStim-S Spine Fusion Stimulator

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BIOLON 1% SODIUM HYALURONATE

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASOSEAL (VASCULAR HEMOSTASIS DEVICE)

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·TRIDYNE VASCULAR SEALANT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·CentriMag Circulatory Support System