ZIKON 100 DIGITAL X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IMAGING JET SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

System, X-Ray, Fluoroscopic, Non-Image-Intensified

FDA classification

FDA Class 2 ·System, X-Ray, Fluoroscopic, Non-Image-Intensified

Thermofit

FDA 510(k)

FDA Class 2 ·Radiology

ZSFab Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Jac-Cell Medic testers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CloudTMS Edge for OCD

FDA 510(k)

FDA Class 2 ·Neurology

VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH

FDA 510(k)

FDA Class 2 ·Hematology

Bone Cement-Normal Viscosity

FDA 510(k)

FDA Class 2 ·Orthopedic

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MURRAY CHAIR LIFT

FDA 510(k)

FDA Class 2 ·General Hospital

TRANSONIC FLOWMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD; AND CYCLOSPORINE MONOCLONAL WHOLE BLOOD

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES WHOLE BLOOD ASSAY

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE/METABOLITES WHOLE BLOOD

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY