10,000 results · 44ms · Sources: EU EUDAMED, US FDA

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·Implantable Miniature Telescope (IMT)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ARCHITECT Anti-HCV

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·Superion Indirect Decompression System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·NuVasive PCM Cervical Disc

Implantable Pulse Generator

FDA Pre-Market Approval
FDA Class 3 ·OPTIMIZER Smart System

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·Superion Indirect Decompression System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER PRIME HTD CARDIAC ABLATION CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM ; XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval
FDA Class 3 ·Inspire II Upper Airway Stimulator

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY SYSTEM, XIENC

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CHILLI AND CHILLI RPM COOLED ABLATION SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC INTERSTIM TINED LEAD MODELS 3889 & 3093

Diagnostic Low Electric Field

FDA Pre-Market Approval
FDA Class 3 ·MARGINPROBE SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HIGH CYLINDER POWER ACRYSOF IQ TORIC IOLS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·Ventana PD-L1 (SP142) Assay

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T)