Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 & STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·EC-5000 EXCIMER LASER SYSTEM

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S2 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device (PFED)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·Sphere-9 ™ Mapping and Ablation Catheter, Tubing Set

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX (R) CERAMIC TOTAL HIP SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MemoryGel Breast Implants

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER / FRONTIER II / ANTHEM FAMILY OF CRT-P'S

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S