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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ELEVESS

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

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·ReVision Optics Raindrop Near Vision Inlay

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·ARTISAN/VERISYSE PHAKIC IOL

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead

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

FDA Pre-Market Approval

FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE DEVICES & PROMOTE ACCEL DEVICES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·VISIONCARE IMPLANTABLE MINIATURE TELESCOPE

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 MR CORONARY STENT SYSTEM & EXPRESS 2 OTW CORONARY STENT SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AXSYM AFP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Integrated Dual Ballon System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Intellis Spinal Cord Stimulation Systems

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon