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CDRH Recently Approved Devices

These products 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.

Listings

There are 5 listings in this category.

Approved Devices 5

Invitrogen SPOT-Light® HER2 CISH™ Kit The SPOT-Light ® HER2 CISH ™ kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method. (Approved: 7/1/2008)

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Approved Devices 1

Akreos® Posterior Chamber Intraocular Lens Akreos ® 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. A cataract is a gradual thickening, hardening and clouding of the eye's... (Approved: 9/5/2008)

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Approved Devices 2

COBAS TaqMan HBV Test For Use With The High Pure System The COBAS Taqman HBV Test For Use With The High Pure System 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 (deoxyribonucleic acid) is the... (Approved: 9/4/2008)

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Approved Devices 4

T-SPOT.TB T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB). (Approved: 7/25/2008)

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Approved Devices 3

Hoya iSpheric™ Model YA-60BB Intraocular Lens The Hoya iSpheric™ Model YA-60BB IOL is a plastic lens 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 the eye's lens, resulting... (Approved: 9/26/2008)

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