3,082 results · 19ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG; Attesta SR MRI IPG; Relia IPG; Sphera SR MRI IPG

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·Zilver PTX Drug-Eluting Peripheral Stent

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·CyPass Ultra System

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine’s Samaritan® Public Access Automated External Defibrillators

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC™ Ophthalmic Viscosurgical Device

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Stent, Iliac Vein

FDA Pre-Market Approval
FDA Class 3 ·Zilver Vena® Venous Self-Expanding Stent

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval
FDA Class 3 ·T-SPOT®.TB Test

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval
FDA Class 3 ·T-SPOT TB TEST

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·BioMimics 3D Vascular Stent System

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval
FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval
FDA Class 3 ·T-SPOT .TB TEST