Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AIR OPTIX plus HYDRAGLYDE Soft Contact Lenses for Daily and Extended Wear

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressing for Dental Surgery

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1-PIECE LENS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen hemostatic Agent - Fibrillar Form

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Brio Neurostimulation System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE® Injectable Implant

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Axium Neurostimulator System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Genesis Neurostimulation System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·TRIDYNE™ Vascular Sealant

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSure Fix MRI Lead

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Fix Novus Lead; Vitatron Crystalline Active Fixation Lead

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic E

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE® Injectable Implant

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit