Today, the FDA issued a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.
FDA approves first 3-D mammography imaging system
Mammography, screening, 3-D
FDA clears test to help patients with kidney transplants
Zortress, kidney, transplant
f’real® foods Expands Voluntary Recall Of Strawberry Banana Smoothies Due To Potential Peanut Content
– f’real® foods announced today that it has expanded its voluntary recall of f’real® Strawberry Banana Smoothies (Lot # 06/21/2012) produced at Smith Dairy Products Company in Orrville, Ohio. The expansion to additional states is due to customer input regarding the extent of their distribution areas.
Magic Valley Fresh Frozen, Inc. Foods Issues Allergy Alert On Undeclared Milk In Breaded Okra
McAllen, TX Magic Valley Fresh Frozen, Inc. announced today that it is voluntarily recalling breaded okra produced under the HEB label from July 1, 2010 through January 31, 2011 because the product may contain undeclared whey (a milk ingredient).
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f’real® foods Issues Voluntary Recall of Strawberry Banana Smoothies Due to Potential Peanut Content
f’real® foods announced today a voluntary recall of f’real®Strawberry Banana Smoothies (Lot # 06/21/2012) produced at Smith Dairy Products Company in Orrville, Ohio. The company is recalling one specific lot as it may contain peanuts, an undeclared allergen.
St James Smokehouse, Inc, Announces Voluntary Recall of Scotch Reserve Whiskey & Honey Smoked Salmon 4oz Retail Packs Due To Possible Health Risk
St James Smokehouse Inc, is conducting a voluntary recall of Scotch Reserve Whiskey & Honey Smoked Scottish Salmon 4oz retails packs under Lot code:5797 & batch code: 4759 with UPC# 853729001151 due to potential contamination with Listeria Monocytogenes.
Neuro Resource Group, Inc. Informs Customers of Important Information about Triad Group’s Alcohol Prep Pads
Neuro Resource Group, Inc. (NRG) has become aware of the market recall of Triad Group’s alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various brand names. The Triad Group alcohol prep pads are co-packaged and distributed with NRG devices to customers in the United States and internationally.
FDA approves 1st pacemaker designed to work safely during some MRI exams
The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.
BIOSAN LABORATORIES ISSUES ALLERGY ALERT ON UNDECLARED SOY IN VITAMIN AND NUTRITIONAL SUPPLEMENTS
BioSan Laboratories, Inc is conducting a voluntary recall on its products sold under the EssentialsTM and RightFoodTM Brands, as well as Therapeutix Cardio Strength and Innate Cardio Response. These products may contain undeclared soy flour.