2,095 results · 19ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Proclaim DRG Neurostimulator System IPG

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY PULSE GENERATOR, 102/102R

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·EXABLATE

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLUORON

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·DURASOFT 3 (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval
FDA Class 3 ·Exablate 2100/2100V1 System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·INTRAOCULAR LENS MODELS C118;C119;C138 AND C139

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·CELLUGEL

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·EON, EONC, EON MINI, PROTEGE, PROTEGE MRI INPLANTABLE PULSE GENERATORS (IPGS)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES