Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony™ Extended Range Of Vision Intraocular Lens

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·TARGIS SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TESTS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ADJUSTABLE GASTRIC BANDING SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 Delta Ceramic Acetabular System

Placental Alpha Microglobulin-1 Immunoassay

FDA Pre-Market Approval

FDA Class 3 ·PartoSure Test

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER® LA-15 System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP, BLAZER PRIME XP & BLAZER XP RPM CARDIAC ABLATION CATHETERS & STERILE CABLES

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Gore CardioForm Septal Occluder

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD PrepMate

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER AND FRONTIER II FAMILIES OF PACEMAKERS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LV LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM