Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL LI63U

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR SYSTEM

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OIL 5000 SILICONE OIL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·WaterWriter Alpha Spinal Cord Stimulator (SCS) Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-COATING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Cathete

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

FDA Pre-Market Approval

FDA Class 3 ·Quickflex µ, Quartet

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·DERMAGRAFT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS, LOW POROSITY VALVED CONDUIT MODEL 105

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G Pump

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS (PERFILCON) HYDROPHILIC CONTACT LENSES F

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay

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

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO Uni-Directional Navigation Catheter

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·(WEB) Aneurysm Embolization System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF GLUCOSE SENSOR, SOF GLUCOSE SENSOR (MMT-7002, MMT-7003)