US FDA Medical Device Approvals
Implantable Miniature Telescope
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)…
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 411 Immunoassay Analyzer
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)…
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 601 Immunoassay Analyzer
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)…
Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the MODULAR ANALYTICS E170 Immunoassay Analyzer
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)…
Photodynamic Diagnostic D-Light C (PDD) System
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™ Surgical Sealant
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)…
