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The products listed on this page include some of the newest medical technology available. Each product listing contains information about what medical uses the device is approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

OraQuick HCV Rapid Antibody Test 29 Jul 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)

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Implantable Miniature Telescope 19 Jul 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)

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Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 411 Immunoassay Analyzer 14 Jun 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)

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Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the cobas e 601 Immunoassay Analyzer 14 Jun 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)

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Elecsys® Anti-HCV Immunoassay and Elecsys® PreciControl Anti-HCV on the MODULAR ANALYTICS E170 Immunoassay Analyzer 14 Jun 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)

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Photodynamic Diagnostic D-Light C (PDD) System 14 Jun 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)

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Ethicon™ OMNEX™ Surgical Sealant 11 Jun 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)

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Esteem® Implantable Hearing System 20 May 2010

The Esteem® is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function. The Esteem® system includes three implantable components (Sound Processor, Sensor, and Driver), and externa (Approved: 3/17/2010)

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Asthmatx, Inc. Alair Bronchial Thermoplasty System 19 May 2010

The Alair Bronchial Thermoplasty System is composed of a catheter with an electrode that delivers radiofrequency energy2 (a form of electromagnetic energy) directly to the airways of the lungs. A controller unit generates and controls the energy. (Approved: 4/27/2010)

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Quick-Close Vascular Suturing System 23 Apr 2010

The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery). (Approved: 4/8/2010)

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Softec HD Aspheric Posterior Chamber Intraocular Lens 23 Apr 2010

The Softec HD posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 4/12/2010)

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STERIS System 1E (SS1E) Liquid Chemical Sterilant Processing System 6 Apr 2010

The STERIS System 1E (SS1E) is a liquid chemical sterilant processing system. The SS1E can be used to process reusable heat-sensitive devices such as endoscopes and their accessories that cannot be processed using steam. (Approved: 4/5/2010)

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Complete® SE Vascular Stent System (20-100mm lengths) 26 Mar 2010

The Complete SE Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). It consists of two parts, the stent and the delivery system. The stent is an... (Approved: 3/17/2010)

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Express® LD Iliac Premounted Stent System 24 Mar 2010

The Express® LD Iliac Stent is an expandable, mesh-like stainless steel tube. The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter... (Approved: 3/5/2010)

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