CRAIGWELL AID FITTING SYSTEM AFS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CRAIGWELL MASTER HEARING AID MHA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PT (INR) test kit (32 tests)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Eurolyser Diagnostica GmbH·1 device

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

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

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

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

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

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·UVAR XTS PHOTOPHERESIS SYSTEM

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·UVADEX(R) STERILE LIQUID