Date Issued: December 22, 2016 Audiences: Health care providers Pregnant women potentially exposed to Zika Medical Specialties: Primary care, Obstetrics and Gynecology, and Infectious Disease Product: The ZIKV Detect IgM Capture ELISA is manufactured by InBios International, Inc. The test is used for the preliminary (presumptive) detection of Zika virus IgM antibodies in human sera…
Updated Information on 3D Printing of Medical Devices
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Consumer Information on: Dexcom G5 Mobile Continuous Glucose Monitoring System
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: Dexcom G5 Mobile Continuous Glucose Monitoring…
Class I Medical Device Recall: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization
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Information on Medical Cribs Used in Homes and Child Care Settings
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Medical Gloves
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FDA Voice blog: Better Tool to Help Assess LASIK Patients
By: Malvina Eydelman, MD LASIK (laser-assisted in situ keratomileusis) eye surgery is an alternative for patients who need glasses or contacts to see well. Some 600,000 to 800,000 patients undergo LASIK in the U.S. each year, and a very high number of those patients are satisfied with their surgical outcomes. However, some patients develop unwanted…
Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals)
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Class I Medical Device Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate
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Emergency Use Authorizations: Zika ELITe MGB® Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…