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. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1 en-us Thu, 02 Jul 2009 10:54:40 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1 The TAXUS® Liberté® Atom™ (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 5/21/2009) Mon, 29 Jun 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm169592.htm http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm169592.htm The BRYAN® Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Approved: 5/12/2009) Wed, 27 May 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm162968.htm http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm162968.htm REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). (Approved: 3/6/2009) Thu, 07 May 2009 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm149812.htm http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm149812.htm The ARCHITECT ® CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen. (Approved: 4/10/2009) Fri, 17 Apr 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080023.html http://www.fda.gov/cdrh/mda/docs/P080023.html The Medtronic® Attain Ability™ Model 4196 Lead (Model 4196) is a surgically implanted insulated wire that is designed to be used as part of a biventricular pacemaker system. (Approved: 4/7/2009) Fri, 17 Apr 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080006.html http://www.fda.gov/cdrh/mda/docs/P080006.html These reagents are used with the Invader Call ReporterTM software to identify DNA from human papillomavirus (HPV) types 16 and 18 in cervical samples. If test results are positive, the patient is likely to be infected with HPV type 16, 18 or both 16... (Approved: 3/12/2009) Mon, 13 Apr 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080015.html http://www.fda.gov/cdrh/mda/docs/P080015.html These reagents are used with the Invader Call Reporter TM softwareto identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. If test results are positive, the patient is likely to... (Approved: 3/12/2009) Mon, 13 Apr 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080014.html http://www.fda.gov/cdrh/mda/docs/P080014.html The FC2 female condom is a sheath with one open end. There is an outer ring at the open end, and, although not attached to the condom, there is an inner ring inside the sheath that aids in insertion. (Approved: 3/10/2009) Mon, 13 Apr 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080002.html http://www.fda.gov/cdrh/mda/docs/P080002.html Synvisc-One™ (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan polymers (derivatives of hyaluronan or sodium hyaluronate) produced from chicken combs. Synvisc-One is a single 6 mL injection treatment regimen. The total... (Approved: 2/26/2009) Mon, 13 Apr 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P940015S012.html http://www.fda.gov/cdrh/mda/docs/P940015S012.html The LifeStent FlexStar and FlexStar XL Vascular Stent Systems are used to re-open stenotic (narrowed) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. (Approved: 2/13/2009) Mon, 09 Mar 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P070014.html http://www.fda.gov/cdrh/mda/docs/P070014.html The NAVISTAR® THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter is used to destroy (ablate) abnormal heart tissue that causes an intermittent abnormal heartbeat in the upper chambers of the heart (paroxysmal atrial fibrillation). (Approved: 2/6/2009) Mon, 09 Mar 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P030031S011.html http://www.fda.gov/cdrh/mda/docs/P030031S011.html The AVS, Inc. XACT ® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL is plastic lens used to replace the natural lens after it is removed during cataract surgery to restore vision. (Approved: 2/2/2009) Mon, 09 Mar 2009 04:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080021.html http://www.fda.gov/cdrh/mda/docs/P080021.html What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies. (Approved: 2/19/2009) Tue, 03 Mar 2009 05:00:00 GMT http://www.fda.gov/cdrh/mda/docs/H050003.html http://www.fda.gov/cdrh/mda/docs/H050003.html The TECNIS® Multifocal Foldable Intraocular Lens is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 1/16/2009) Fri, 30 Jan 2009 05:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080010.html http://www.fda.gov/cdrh/mda/docs/P080010.html BIOFINITY® is an extended wear soft contact lens that may be worn continuously for up to 6 nights and 7 days. The lens material is approximately 48% water and 52% comfilcon A (a silicone-containing hydrogel). (Approved: 11/19/2008) Wed, 28 Jan 2009 05:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P080011.html http://www.fda.gov/cdrh/mda/docs/P080011.html The Express® SD Renal Monorail® Premounted Stent System is used to re-open stenotic (narrowed) regions of the renal arteries which supply blood to the kidneys, and it consists of two components, the stent and the delivery system. (Approved: 12/11/2008) Wed, 28 Jan 2009 05:00:00 GMT http://www.fda.gov/cdrh/mda/docs/P060006.html http://www.fda.gov/cdrh/mda/docs/P060006.html