Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE LEAD

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·ThinPrep Processors and ThinPrep Imaging System

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·HIGH FREQUENCY OSCILLATING VENTILATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM, ALLURE, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·COSEAL SURGICAL SEALANT DEVICE

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Solesta Injectable Gel

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI UNIPOLAR/BIPOLAR LEADS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·AXSYM FREE PSA (LN 3C20)

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Advia Centaur AFP Immunoassay and Atellica IM AFP Immunoassay

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE LOW VISCOSITY INJECTABLE IMPLANT; RADIESSE (+) LIDOCAINE DERMANL FILTER