Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFE STENT VASCULAR STENT SYSTEM

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Scaffold, Dissection Repair

FDA Pre-Market Approval

FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity Coronary Stent System

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Apollo Onyx Delivery Microcatheter

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL PMS US STUDY NIRTRAKS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS/ISOFLEX S/P/OPTIM

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·BARD FLAIR ENDOVASCULAR STENT GRAFT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PROTEGO DF-1 LEAD FAMILY

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE CORONARY STENT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

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

FDA Pre-Market Approval

FDA Class 3 ·nMARQ Catheter Interference Cable

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

Tester, Acoustic, Bone Quality

FDA Pre-Market Approval

FDA Class 3 ·QUS-2 CALCANEAL ULTRASONOMETER