Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Staumann Emdogain

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

FDA Pre-Market Approval

FDA Class 3 ·LCS® Total Knee System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ENVISTA IOL

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Alpha Thoracic Endovascular Graft

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM VR MODELS 7227 B/D/E/CX

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY PERENNIAFLEX

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 Mobile Continuous Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro-

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINALPAK(R) STIMULATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR