Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC HIGH CYLINDER POWER IOL

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

FDA Pre-Market Approval

FDA Class 3 ·FLEX MOBILE BEARING KNEE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE XVE LVAS

Artificial Iris

FDA Pre-Market Approval

FDA Class 3 ·CustomFlex Artificial Iris

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid L24 Implant System

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH SF Catheter

Catheter, Balloon, Transcervical

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·AUGMENT Bone Graft and AUGMENT Injectable

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION AIR OPTIX AQUA (LOTRAFILCON B) SOFT CONTACT LENSES

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·ORATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS

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

FDA Pre-Market Approval

FDA Class 3 ·CORETHERM SYSTEM MICROWAVE THERMOTHERAPY