Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Lead and Extension Insertion Tool

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim family of SCS IPGs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Intraocular Lenses

Test System, For Drugs Of Abuse

FDA classification

FDA Class 3 ·Test System, For Drugs Of Abuse

Paraquat Assay

FDA classification

FDA Class 3 ·Paraquat Assay

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification

FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

Placental Alpha Microglobulin-1 Immunoassay

FDA classification

FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay