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

FDA Pre-Market Approval

FDA Class 3 ·Transcend Hip Articulation System

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·COSMETIC TISSUE AUGMENTATION PRODUCT

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas

Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

FDA Pre-Market Approval

FDA Class 3 ·eCoin implanted tibial stimulator

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OSTEOGEN BONE GROWTH IMPLANTABLE BONE GROWTH STIMULATOR

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·OSTEONICS ABC/TRIDENT SYSTEMS

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·ASCENSION MCP