Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Evoke® SCS System

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO PLASMAFILTER, PF2000N

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ARTEFILL

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

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

FDA Pre-Market Approval

FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA Pre-Market Approval

FDA Class 3 ·SLEEP SENTRY(TM)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO PRISMAFLEX TPE 2000 SET

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Evoke® SCS System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PRISMAFLEX TPE2000 SET

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

FDA Pre-Market Approval

FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Evoke SCS System

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERES