Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PR/ VENTAK MINI

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR MODELS H120 AND H125

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CONTINUOUS GLUCOSE MONITORING SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Allure, Allure RF, Allure Quadra, Allure Quadra RF - PM3120, PM3222, PM3140, PM3242

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD PARTIAL KNEE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS(R) TOTAL KNEE SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epicardial Patch Lead

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UroVysion Bladder Cancer Kit

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·BIOCOR, EPIC AND EPIC SUPRA VALVE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM