10,000 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·TENDRIL FAMILIES OF LEADS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK LOW POROSITY VALVED CONDUIT
Automated Insulin Dosing , Threshold Suspend
FDA Pre-Market Approval
FDA Class 3
·t:slim X2 Insulin Pump with Basal-IQ Technology
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·Guardant360 CDx
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·CRCDx RAS Mutation Detection Assay Kit
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·MULTI-LINK VISION RX ZETA CORONARY STENT SYSTEMS
Leadless Pacemaker
FDA Pre-Market Approval
FDA Class 3
·Aveir
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Joint, Temporomandibular, Implant
FDA Pre-Market Approval
FDA Class 3
·TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st
Agent, Injectable, Embolic
FDA Pre-Market Approval
FDA Class 3
·ONYX LIQUID EMBOLIC SYSTEM
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·THERAPY ABLATION CATHETER
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DURATA FAMILY OF LEADS
Filler, Bone Void, Non-Osteoinduction
FDA Pre-Market Approval
FDA Class 3
·COLLAGRAFT STRIP BONE GRAFT MATRIX
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·AFX2 Endovascular AAA System
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·JUVEDERM VOLUMA XC
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses