Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA Pre-Market Approval

FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMP DPS SOFTWARE

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device (Model Number FGS-7000)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMP DPS SOFTWARE

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

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Ceramax Ceramic Total Hip System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Ceramax Ceramic Total Hip System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip™ G4 Clip Delivery System

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 System

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 System

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip G4 System

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip™ G4 Clip Delivery System

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TriClip™ G4 Delivery System; MitraClip™ G5 Delivery System, TriClip™ G5 Delivery System