10,000 results
·
114ms
·
Sources: EU EUDAMED, US FDA
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX De
Agent, Occluding, Vascular, Permanent
FDA Pre-Market Approval
FDA Class 3
·VenaSeal Closure System
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·SENSAR 3PC & 1PC MONOFOCAL; TECNIS 1PC MONOFOCAL, 1PC MULTIFOCAL AND 1PC TORIC MONOFOCAL, 1PC OPTIBULE & 3PC OPTIBLUE
Agent, Injectable, Embolic
FDA Pre-Market Approval
FDA Class 3
·Apollo Onyx Delivery Micro Catheter
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC ONE
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANCURE ENDOCRAFT SYSTEM
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Spinal Cord Stimulator System
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI
Continuous Glucose Monitor, Implanted, Adjunctive Use
FDA Pre-Market Approval
FDA Class 3
·Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·REZOOM 3-PC MULTIFOCAL
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, Avant, Neutrino NxT, Gallant, Entrant
Automated Insulin Dosing Device System, Single Hormonal Control
FDA Pre-Market Approval
FDA Class 3
·MiniMed 670G System, MiniMedTM 770G System
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·PROVISC Ophthalmic Viscosurgical Device
Prosthesis, Penis, Inflatable
FDA Pre-Market Approval
FDA Class 3
·AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment
FDA Pre-Market Approval
BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D