Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR Plus

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490D CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR ENPULSE MODELS

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

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 60 (OCUFILICON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifoconA)/ Contact Lenses for Overnight Wear/Euclid Systems Orthokeratology (tisilfoco

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490G/ 2490H/2490J CARELINK MONITORS FOR USE WITH MODEL 2491 DDMA SOFTWARE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon A and Lotrafilcon B soft contact lenses for daily and extended wear

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD, SPLITTER/ADAPTOR, DF-4 IMPLANT TOOL KIT FOR MDT LEADS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) and (tisilfocon A) Contact Lenses for Overnight Wear

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES

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