PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Freedom® Total Knee System – Titanium Tibial Base Plate

FDA 510(k)

FDA Class 2 ·Orthopedic

Radialis PET Camera

FDA 510(k)

FDA Class 2 ·Radiology

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA Test System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM/TOTAL PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY