Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR STENT DELIVERY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR PREMOUNTED STENT DELIVERY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR PREMOUNTED STENT DELIVERY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY X4 E24 Molding NOR Optimization

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Cellex Photopheresis System

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·TPS 102 PHOTOCEPTOR ACTIVATION CHAMBER

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·UVAR PHOTOPHORESIS SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·UVAR XTS PROCEDURAL KIT

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS