The Boston Scientific LIVIAN, COGNIS, and CONTAK RENEWAL 3 RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT). (Approved: 9/16/2010)

The KODAK DirectView CR Mammography System consists of the KODAK DirectView CR Mammography Cassette with EHR-M Screen designed to fit into the Bucky device of standard mammography x-ray equipment, and the KODAK DirectView CR Mammography Feature Software.. (Approved: 11/3/2010)

HER2 FISH pharmDx™ is a laboratory test that uses DNA probes with fluorescent dyes attached to count how many copies of the HER2 gene, located on chromosome 17, are present in a cancer tissue sample. (Approved: 10/20/2010)

HercepTest is a laboratory test that measures how much Her2 protein is being made by the cancer cells. This test has been used in patients with breast cancer and now can be used in patients with spreading (metastatic) stomach (gastric) cancer. (Approved: 10/20/2010)

The EC-3 Posterior Chamber IOLs (Models EC-3 and EC-3 PAL) are artificial lenses used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of... (Approved: 10/19/2010)

Abbott RealTime HBV is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA is the genetic material from the hepatitis B virus. (Approved: 8/13/2010)

The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies... (Approved: 6/25/2010)

The VisionCare Ophthalmic Technologies Implantable Miniature Telescope TM (IMT) is a system to magnify objects to improve vision in patients with end-stage, age-related macular degeneration (AMD). The IMT is surgically implanted in one eye only and is... (Approved: 7/1/2010)

The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 4/29/2010)

The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 4/29/2010)

The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 4/29/2010)

The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System is used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview® (Photocure ASA, a Norwegian pharmaceutical company). (Approved: 5/28/2010)

Ethicon™ OMNEX™ is a medical sealant that is used to help stop leaks in blood vessels. It is made of two synthetic components called cyanoacrylate monomers, and does not include any human or animal materials. (Approved: 6/3/2010)