2,109 results · 20ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·ANS EON C (IPG) NEUROSTIMULATION SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

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

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

Stimulator, Autonomic Nerve, Implanted For Epilepsy

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT(TM)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DUOVISC VISCOELASTIC SYSTEM

Dorsal Root Ganglion Stimulator For Pain Relief

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS NEUROSTIMULATION (IPG) SYSTEM

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® Intraocular Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON A & B SOFT CONTACT LENSES

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR Ankle)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Posterior Chamber Single Piece Intraocular Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS