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

FDA Pre-Market Approval

FDA Class 3 ·R3 Delta Ceramic Hip System

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ESSURE SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Orbera Intragastric Balloon

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER Muscular VSD Occluder

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·nMARQ Catheter Interference Cable

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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT ENDOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·CORETHERM SYSTEM MICROWAVE THERMOTHERAPY

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·Cartiva Synthetic Cartilage Implant (SCI)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify Cervical Artificial Disc

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·iWear oxygen and iWear oxygen astigmatism

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE(R) SYSTEM

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·TRULIGN TORIC POSTER CHAMBER INTRAOCULAR LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VERSATRAX PACING SYSTEM

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST