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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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Amy's Kitchen Recalls Various Products Because of Possible Health Risk by FDA Posted in: Blog Posts in Health Education Amy's Kitchen, Inc. is voluntarily recalling approximately 73,897 cases of select code dates and manufacturing codes of the products identified on Attachment A. This recall ... Read on »
Wegmans Announces Recall of (Frozen) Wegmans Organic Food You Feel Good About Just Picked Spinach,... by FDA Posted in: Blog Posts in Health Education Wegmans Food Markets, Inc. is recalling approximately 12,540 packages of Wegmans Organic Food You Feel Good About Just Picked Frozen Spinach, 12 oz. (UPC 77890-32932) due to ... Read on »
Federal Register: Medical Devices; Neurological Devices; Classification of the Limited Output... by FDA Posted in: Blog Posts in Health Education The FDA is classifying the limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites into class II (special controls). The speci ... Read on »
Voluntary Recall for Potential Health Risk O’Coconut ™ by FDA Posted in: Blog Posts in Health Education Nutiva, an Organic Superfoods company, has initiated a voluntary product recall of the following O’Coconut™ products after being notified by supplier that samples of a raw m ... Read on »
Aurora Products, Inc. Voluntarily Recalls Certain Aurora Natural Brand and Certain Private Label... by FDA Posted in: Blog Posts in Health Education Aurora Products, Inc. is conducting a voluntary nationwide recall of certain lots of NATURAL WALNUTS and TRAIL MIXES CONTAINING WALNUTS because they have the potential to co ... Read on »
Texas Star Nut and Food Co. Inc. Natural Macadamia Nuts Are Being Voluntarily Recalled Due To... by FDA Posted in: Blog Posts in Health Education Texas Star Nut and Food Co., Inc. of Boerne, Texas is voluntarily recalling Nature’s Eats Natural Macadamia Nuts, Lot Code #31435001, because it has the potential to be cont ... Read on »
La Terra Fina Recalls Organic Spinach Dip Sold in Bay Area Costco Clubs by FDA Posted in: Blog Posts in Health Education La Terra Fina is issuing a voluntary recall of its Organic Spinach Dip due to a potential health risk from Listeria exposure. The recall of product available in Bay Area Cos ... Read on »
Giant Eagle Voluntarily Recalls Raisin Filled and Apricot Filled Cookies Due to an Undeclared Milk... by FDA Posted in: Blog Posts in Health Education All lots of Giant Eagle brand Raisin Filled and Apricot Filled cookies, baked and sold individually from the Bakery department service counters inside Giant Eagle and Market ... Read on »
Taylor Farms Florida Issues Allergen Alert on Undeclared Soy in Kale and Quinoa Salad by FDA Posted in: Blog Posts in Health Education Taylor Farms Florida Inc., of Orlando, FL is voluntarily recalling a limited quantity of Kale and Quinoa Salad because they have the potential of containing an undeclared so ... Read on »
Giant Eagle Voluntary Recall of Bakery Seasonal Cut-Out Shapes Cookies Due to Undeclared Milk... by FDA Posted in: Blog Posts in Health Education All lots of Giant Eagle brand seasonal cut-out shapes cookies, baked and sold inside Giant Eagle and Market District supermarkets through March 18, have been voluntarily rec ... Read on »
Summary Information for: TECNIS Multifocal 1-Piece Intraocular Lens (IOL), Models ZKB00 (+2.75 D)... by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for TECNIS Multifocal 1-Piece Intraocular Lens (IOL), Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D) (P980040S0 ... Read on »
Consumer Information on: TECNIS Multifocal 1-Piece Intraocular Lens (IOL), Models ZKB00 (+2.75 D)... by FDA Posted in: Blog Posts in Health Education TECNIS Multifocal IOLs, Models ZKB00 and ZLB00, are artificial lenses. The IOL is implanted inside the eye to replace the natural lens after its removal due to clouding (cat ... Read on »
Consumer Information on: ResQCPR System: ResQPump (ACD-CPR device) and ResQPOD ITD 16 - P110024 by FDA Posted in: Blog Posts in Health Education The ResQCPR System consists of two devices that are used together by trained paramedics and emergency medical technicians while performing CPR on people whose hearts stop pu ... Read on »
Summary Information for: ResQCPR System: ResQPump (ACD-CPR device) and ResQPOD ITD 16 by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for ResQCPR System: ResQPump (ACD-CPR device) and ResQPOD ITD 16 (P110024). Read on »
Summary Information for: Progel Pleural Air Leak Sealant by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for Progel Pleural Air Leak Sealant (P010047S036). Read on »
Consumer Information on: Progel Pleural Air Leak Sealant - P010047S036 by FDA Posted in: Blog Posts in Health Education The Progel Pleural Air Leak Sealant is a surgical sealant made of human blood protein and a chemical compound. When mixed together, they form a clear, flexible gel. Surgeons ... Read on »
PMA Final Decisions for January 2015 by FDA Posted in: Blog Posts in Health Education These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for January 2015. Read on »
PMA Final Decisions for December 2014 by FDA Posted in: Blog Posts in Health Education These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for December 2014. Read on »
Mammography Facility Adverse Event and Action Report - March 19, 2015 by FDA Posted in: Blog Posts in Health Education As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipul ... Read on »
Summary Information for: Lixelle Beta 2-microglobulin Apheresis Column by FDA Posted in: Blog Posts in Health Education Labeling, Approval Order, and Summary of Safety and Effectiveness for Lixelle Beta 2-microglobulin Apheresis Column (H130001). Read on »