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News & Events

Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Public Health Notifications:
Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning
Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Class I Medical Device Recalls -
Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs)
Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

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