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The Web site of the US Food and Drug Administration (http://www.fda.gov) The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices.  FDA is responsible for ... Full Bio
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Summary Information for: XIENCE V® and XIENCE nano® Everolimus Eluting Coronary Stent... by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for XIENCE V® and XIENCE nano® Everolimus Eluting Coronary Stent System (P070015S122). Read on »
Summary Information for: XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent... by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition®, XIENCE Xp ... Read on »
Consumer Information on: XIENCE Family of Everolimus Eluting Coronary Stent Systems - P070015/S122... by FDA Posted in: Blog Posts in Health Education The XIENCE Family of Everolimus Eluting Coronary Stent Systems (EECSSs) consists of stent that is coated with the drug everolimus and a delivery catheter. The stent is made ... Read on »
Consumer Information on: Lutonix 035 Drug Coated Balloon PTA Catheter - P130024 by FDA Posted in: Blog Posts in Health Education The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) uses a drug-coated balloon to re-open blocked or narrowed arteries in the th ... Read on »
FDA Voice Blog: FDA Encourages Development of Devices for Patients with Disabilities by FDA Posted in: Blog Posts in Health Education For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medication ... Read on »
FDA Voice Blog: FDA as part of a coordinated global response on Ebola by FDA Posted in: Blog Posts in Health Education The tragic Ebola epidemic is an extraordinary global public health crisis, and FDA is taking extraordinary steps to be proactive and flexible in our response ? whether it?s ... Read on »
Chetak New York L.L.C. Recalls 7 Oz., 14 Oz., & 28 Oz. Packages of "Deep Raw Cashew Pieces"... by FDA Posted in: Blog Posts in Health Education Chetak New York L.L.C. of Edison, NJ is recalling its 5560 packages of 7oz., 3840 packages of 14oz., & 1920 packages of 28oz. "DEEP RAW CASHEW PIECES" because they have the ... Read on »
Whole Foods Market Melrose Recalls Vegan Gingersnap Cookies Due to Mislabeling and Undeclared... by FDA Posted in: Blog Posts in Health Education Whole Foods Market is recalling Vegan Gingersnap Cookies produced and sold only in the Melrose, Massachusetts location due to a labeling error that resulted in undeclared tr ... Read on »
Shur-Green Farms Issues Voluntary Nationwide Recall of Lascadoil/Soyoil Due to Possible Lasalocid... by FDA Posted in: Blog Posts in Health Education Shur-Green Farms LLC(Ansonia, OH) has voluntarily recalled loads of Soyoil containing Lascadoil, industrial processing waste oil, which was intended for non-food product or ... Read on »
Z Natural Foods Recalls Lightly Roasted Organic Carob Powder Due to Possible Salmonella Health Risk by FDA Posted in: Blog Posts in Health Education Z Natural Foods of West Palm Beach, Florida is recalling 55 lbs of Lightly Roasted Organic Carob Powder because it has the potential to be contaminated with Salmonella, an o ... Read on »
Transcript posted for October 1, 2014 Gastroenterology and Urology Devices Panel of the Medical... by FDA Posted in: Blog Posts in Health Education Transcript posted for October 1, 2014 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Read on »
Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes by FDA Posted in: Blog Posts in Health Education Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the br ... Read on »
Lundberg Family Farms Recalls Sea Salt Rice Chips Due to Undeclared Allergen by FDA Posted in: Blog Posts in Health Education Lundberg Family Farms announced that it is voluntarily recalling from distribution in the United States and Canada, specific bags of Sea Salt Rice Chips due to possible pres ... Read on »
Baxter Initiates Voluntary Recall of Two Lots of Intravia Containers in the U.S. and Canada by FDA Posted in: Blog Posts in Health Education Baxter International Inc. announced today it is voluntarily recalling two lots of INTRAVIA containers in the U.S. and Canada due to complaints received for particulate matte ... Read on »
Rome Packing Co., Inc. Recalls Fresh And Frozen Crab Meat Because Of Possible Health Risk by FDA Posted in: Blog Posts in Health Education Rome Packing Co., Inc. has issued a voluntary recall of Ocean’s Catch brand All Natural Jonah Crab Leg Meat after routine product sampling by the company de ... Read on »
Bailey Farms Inc. Recalls Fresh Serrano Chile Peppers Because Of Possible Health Risk by FDA Posted in: Blog Posts in Health Education Bailey Farms, Inc. of Oxford, NC is voluntarily recalling 6,215 pounds of Fresh Serrano Chile Peppers, because it has the potential to be contaminated with Salmonella, an or ... Read on »
Contract Packaging Resources, Inc. Issues a Voluntary Nationwide Recall of Assured Brand Naproxen... by FDA Posted in: Blog Posts in Health Education Greensboro, N.C., Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some carto ... Read on »
Class I Medical Device Recall: Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes... by FDA Posted in: Blog Posts in Health Education These defibrillation electrodes have been recalled because Philips made changes to the design of their connectors for the FR3 and FRx AEDs. Because of these changes, the Cov ... Read on »
Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the... by FDA Posted in: Blog Posts in Health Education Nucleic acid-based in vitro diagnostic devices for the detection of MTB-complex and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory sp ... Read on »
JFC International Inc. Issues Allergy Alert on Undeclared Milk in 'Hapi Pudding' by FDA Posted in: Blog Posts in Health Education JFC International Inc. of Los Angeles, CA is voluntarily recalling all lot codes of its 3-pack Hapi Pudding with a net weight of 8.46 ounces (UPC 11152 13417), because they ... Read on »