Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. RADIANZ™ Vascular Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. RADIANZ™ Vascular Stent System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Maestro 4000 Cardiac Ablation System (Controller, Remote and Pods)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, E

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM,DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ASSORTED MOD. C LOOPS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ASSORTED MOD. C LOOPS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR IQ IOL

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC INTRAOCULAR LENS (IOL)

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL