Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDY LAR PROSTHESIS SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HR HPV Assay

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV Assay

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

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