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Webinar – Final Guidance Documents: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
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Class I Medical Device Recall: Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10
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Webinar – CDRH Industry Basics Workshop: The Quality System
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Software as a Medical Device (SaMD): Clinical Evaluation
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UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T Heater-Cooler System: FDA Safety Communication
October 13, 2016 Audiences: Health care providers who use 3T Heater-Cooler System Primary care providers who are responsible for the ongoing care of patients who have undergone cardiothoracic surgery Patients who have undergone cardiothoracic surgery Hospital staff who are responsible for operating and maintaining 3T Heater-Cooler System Health care facilities that perform procedures using the…
Emergency Use Authorization Amendment: Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics)
On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.’s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria…
Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication
Date Issued: October 11, 2016 Audience: Patients with a St. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device Caregivers of patients with a St. Jude Medical ICD and CRT-D device Cardiologists, electrophysiologists, cardiac surgeons, primary care physicians treating patients with heart failure or heart rhythm problems Medical Specialties: Cardiac Electrophysiology,…
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
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Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use
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