Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL FAMILIES

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

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

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

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 SERUM ASSAY

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

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL 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 ·TD CYCLOSPORINE AND METABOLITES SERUM ASSAY