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

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION Ceramic Acetabular Hip System (RCHS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLE UV40 POSTERIOR CHAMBER LENS

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VisuMax Femtosecond Laser

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2100 SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DISCOVISC Ophthalmic Viscosurgical Device

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC-L TOTAL DISC REPLACEMENT

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX PLUS EXCIMER LASER WORKSTATION

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT CAGE LUMBAR TAPERED FUSION DEVICE

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX CERAMIC TOTAL HIP SYSTEM

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE IOL

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·AEGEA Vapor System, Aegea Vapor Probe Procedure Kit, Aegea Vapor Generator and Aegea Vapor Generator Accessory Kit