October 20, 2016 Dear Radiation Oncologists, Medical Physicists, Dosimetrists, and Radiation Therapists: The FDA is concerned about the risks to patients from the use of devices manufactured and sold by Multidata Systems International Corporation (“Multidata”). The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the United States…
Class I Medical Device Recall: TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use
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Medtronic Neurovascular Products: Recall
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150033 added)
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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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Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall
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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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Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication
[Posted 10/13/2016] AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing ISSUE: FDA is updating its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the Stӧckert 3T Heater-Cooler System (3T) in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations…
Software as a Medical Device (SaMD): Clinical Evaluation
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