Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY(TM) VAGINAL POUCH

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·FC2 FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

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

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

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

GEMENI IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO HUMAN IGM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ACS CORONARY GUIDING

FDA 510(k)

FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M

FDA 510(k)

FDA Class 2 ·Immunology

SPIFE URINE IFE

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Ebony PTA 0.035 Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Amethyst HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA .014 RX Pheripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular