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

Ventricular (Assist) Bypass

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

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1CDx)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Aid, Surgical, Viscoelastic

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

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLUMA XC

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLQTINUM CHROMIUM STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·REVISION OPTICS RAINDROP NEAR VISION INLAY

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA MULTI-PIECE POSTERIOR CHAMBER IOLS

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL MINI SINUS IMPLANTS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·StarClose SE Vascular Surgical System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·E-LUMINEXX VASCULAR STENT

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY