Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE NEUROSTIMULATORS FOR SPINAL CORD STIMULATION

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus™ Deep Brain Stimulation (DBS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA THERAPY FOR DBS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled and SPECTRUM® Breast Implants

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 018

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 day (omafilcon A)

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryGel® Silicone Gel-Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryShape™ Breast Implants

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 day (omafilcon A)

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON - TB GOLD IN-TUBE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM® Absorbable Gelatin Sponge, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SU

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants