Boyd Coatings Research Co., Inc. has announced the availability of six PTFE colors – all of which are created with the company's new, fully-validated and FDA-compliant, Zero PFOA PTFE formula. Colors include blue, black, green, white, ...
Tags: Coatings
FDA has approved its single- and dual-chamber Entovis pacemakers for use in MRI environments, according to Biotronik Inc. The Lake Oswego, OR–based US subsidiary of Biotronik SE & Co. KG (Berlin) said in a press release that its ...
Blood glucose test strips sold in these packages have been declared misbranded by FDA and should not be used. (Courtesy FDA) FDA has announced the recommendation that use of Shasta Technologies' GenStrip Glucose Test Strips be ...
Tags: FDA, Certification, Health, Medicine
Sorin's just-approved Mitroflow valve (Courtesy Sorin Group) Italy's Sorin Group has announced that FDA has given its approval to the latest iteration of the company's Sorin Mitroflow aortic pericardial heart valve. This newest version ...
The FDA is providing the Medical Device Innovation Consortium (MDIC) with nearly $500,000 to conduct research to better understand patient preferences, and how to integrate such preferences into the development of medical devices, the group ...
Food safety, product tracing, and product recalls are currently at the forefront of both government regulations and industry concerns around the world as the industry prepares for new regulations around certain non-food, non-healthcare ...
Tags: Packaging, Printing, Food safety
Intuitive Surgical stock fell 11.5% in value on Wednesday after a disappointing quarterly earnings report and the FDA raising cancer concerns over how robotic hysterectomies are performed. The Sunnyvale, CA–based maker of da Vinci ...
The common stock of healthcare and medical device giant Johnson & Johnson (JNJ) soared to recent highs following the company's announcement of first quarter results that beat analysts' estimates. The company's robust performance was ...
Tags: Health, Medicine, medical device
The FDA appears to be issuing another Class I designation involving Abbott Laboratories' voluntary recall of diabetes products. Back in January, the FDA said FreeStyle and FreeStyle Lite test strips could cause serious injury or death ...
A study of 25 high-risk medical devices approved for use on children showed that 84 percent of those devices approved by FDA since 2008 had not been tested on any child under 18 years of age before the approval was granted. Eleven had not ...
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.[1] This ...
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Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) ...
Tags: QSR, certification
The United States Food and Drug Administration (FDA) Introduction FDA (FDA) under the United States Department of Health Education and Welfare, is responsible for the drugs, food, biological products, cosmetics, veterinary drugs, ...
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�� food products �� medical equipment products �� cosmetics �� radiation electronic products �� nutrition and health products �� Chinese herbal ...
Tags: FDA, FDA Certification, certification
FDA Bid Forms 1,A food category (FOOD) : refers to the ordinary foodstuffs, with the exception of health examination also need to produce nutrition labeling.Beverages and canned food needed for FCE (Factories registered), SID ...
Tags: FDA, FDA Certification, certification