Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM

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)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL NT HEMOSTATIC MATRIX

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EBI BONE HEALING SYSTEM(R)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead

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

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·KONTUR 55 EW

HEARTSINE SAMARITAN PAD 350P

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ANTENNA AND PORTABLE CHARGER

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

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System