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Società Italiana di Radiologia Medica

Radiodiagnostica
Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff (PDF - 224KB)
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RadiodiagnosticaThis guidance addresses testing and labeling of passive implants for safety and compatibility in the magnetic resonance (MR) environment. In preparing a premarket approval application (PMA), Investigational Device Exemption (IDE), and premarket notif ... ...
 
Federal Register: Orthopaedi c and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting
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RadiodiagnosticaThe FDA is postponing the meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory scheduled for December 12, 2014. ... ...
 
POSTPONED December 12, 2014: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting
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RadiodiagnosticaPOSTPONED December 12, 2014: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting ... ...
 
Transcript posted for November 14, 2014 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
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RadiodiagnosticaTranscript posted for November 14, 2014 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting ... ...
 
FDA Voice Blog: Implementing the Unique Device Identifier System into health care systems is critical for reaching its potential to benefit public health
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RadiodiagnosticaAs the FDA works with manufacturers to launch a new system of identifying medical devices using standard bar codes and numbers, we look forward to the day when the system, called the Unique Device Identifier (UDI) system, will be fully set up... ... ...
 
510(k) Final Decisions - November 2014
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Radiodiagnostica510(K) summaries or 510(K) statements for final decisions rendered during the period of November 2014. ... ...
 
Class I Medical Device Recall: CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs
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RadiodiagnosticaPhilips made changes to the connector design of their FR3 and FRx AEDs. Because of these changes, the CONMED electrodes will no longer work with these AEDs. The FRx AED requires electrode pads be connected to the device before it is used. The AED wil ... ...
 
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