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Società Italiana di Radiologia Medica

Radiodiagnostica
24 Hour Summary posted for February 27, 2015 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
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Radiodiagnostica24 Hour Summary posted for February 27, 2015 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee ... ...
 
Presentation and Transcript added to Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories - February 24, 2015
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Radiodiagnostica On February 6, 2015, the FDA posted final guidance documents on medical device data systems (MDDS) and mobile medical apps (MMA). We also recently posted draft guidance on our general wellness policy for low risk devices and medical device... ... ...
 
Class I Medical Device Recall: HeartWare Ventricular Assist System (VAS) Electrostatic Discharge May Cause Pump Failure
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RadiodiagnosticaA buildup of static may cause a sudden discharge of electricity (electrostatic discharge) in the device. When this happens, data in the motor controller that manages the pump?s operation may be corrupted and the device may stop working. ... ...
 
Federal Register: Medical Device Reporting: Electronic Submission Requirements; Correcting Amendments
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RadiodiagnosticaThe FDA is amending its regulation regarding postmarket electronic Medical Device Reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations and to update the contact info. ... ...
 
Consumer Information on: VenaSeal Closure System - P140018
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RadiodiagnosticaThe VenaSeal Closure System (VenaSeal System) is intended to permanently treat varicose veins of the legs that cause symptoms by sealing the affected veins that are closest to the skin (superficial varicose veins) with a cyanoacrylate-based adhesive. ... ...
 
Federal Register: Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Embryo Image Assessment System
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RadiodiagnosticaThe FDA is classifying the Assisted Reproduction Embryo Image Assessment System into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the... ... ...
 
Emergency Use Authorizations (February 25 - Added ReEBOV Antigen Rapid Test)
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RadiodiagnosticaAdded documents for the ReEBOV? Antigen Rapid Test. ... ...
 
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