Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·600C ASPHERIC INTRAOCULAR LENS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·ACTIVL ARTIFICIAL DISC

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA Pre-Market Approval

FDA Class 3 ·DIABETES SENTRY

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERE MICROSPHERES

Gonococcal Antibody Tests

FDA Pre-Market Approval

FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MARGINPROBE SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR Excimer Laser

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·GAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N

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 ·Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Prismaflex TPE2000 Set

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERES MICROSPHERES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio; STAR Excimer Laser System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Gambro Prismaflex TPE 2000 Set