System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Epi proColon

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

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

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM

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 ·Gambro Prismaflex TPE 2000 Set

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 EXCIMER LASER AND WAVESCAN WAVEFRONT SYSTEMS

Excimer Laser System

FDA Pre-Market Approval

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGNRefractive Studio, STAR Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDesign Advanced WaveScan Studio

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke® SCS System; Implantable Pulse Generator (Model 3042)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA Pre-Market Approval

FDA Class 3 ·DIABETES SENTRY

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Prismaflex TPE2000 Set

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR, S41R EXCIMER LASER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants