10,000 results · 58ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRO TOPOLYZER VARIO

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

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VIEWPOINT(TM) CK SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A)

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

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS Therapy 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)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Stimulator, Autonomic Nerve, Implanted For Epilepsy

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