This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: InterStim® Therapy System PMA Applicant:…
Class I Medical Device Recall: Maquet Cardiovascular, LLC, Heartstring II Proximal Seal System (HS-1045)
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Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments
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Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
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Jobs at the Center for Biologics Evaluation and Research (CBER)
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Celerite Slimming Tea: Recall
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Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and D
[Posted 03/29/2011] AUDIENCE: Consumer ISSUE: Tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. Intake of excessively high levels of these vitamins poses a risk to human health. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness,…
Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall – Potential for Under
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Single-Ingredient Oral Colchicine Video
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Long-Acting Beta-Agonists (LABAs) Video
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