Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS/EQUALENS II

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Attune Revision Tibial Augments

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DURASOFT(R) 3 FOR EXT WEAR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PC-40NJB (TIER)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Gel-One

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC TM VISCOELASTIC PREPARATION

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX TOTAL HIP SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System & Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator S

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Knee System, ATTUNETM Revi

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOSTIM(R)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·J LOOP POSTERIOR CHAMBER TYPE II 0 & 10