3,169 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·IPure Preloaded IOL System
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·AUGMENT Bone Graft and AUGMENT Injectable
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
FDA Pre-Market Approval
FDA Class 3
·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Stimulator, Carotid Sinus Nerve
FDA Pre-Market Approval
FDA Class 3
·Barostim System
Diagnostic Low Electric Field
FDA Pre-Market Approval
FDA Class 3
·MarginProbe System
Lens, Intraocular, Phakic
FDA Pre-Market Approval
FDA Class 3
·EVO/EVO+ VISIAN® Implantable Collamer® Lenses
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Proclaim Family of Implantable Pulse Generators
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
Mitral Valve Repair Devices
FDA Pre-Market Approval
FDA Class 3
·MitraClip G4 Clip Delivery System
Stent Graft, Infrapopliteal, Venous Arterialization
FDA Pre-Market Approval
FDA Class 3
·LimFlow System
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS Total Knee System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG
Reherniation Reduction Device
FDA Pre-Market Approval
FDA Class 3
·Barricaid Anular Closure Device
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·TECNIS Multifocal Toric II Intraocular Lenses
Implant, Anti-Gastroesophageal Reflux
FDA Pre-Market Approval
FDA Class 3
·LINX REFLUX MANAGEMENT SYSTEM
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Nucleus 24 Cochlear Implant System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EDWARDS SAPIEN TRANSCATHETER HEART VALVE
System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
FDA Pre-Market Approval
FDA Class 3
·UROLOGIX TARGIS SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·SJM ISOFLEX OPTIM LEADS