BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Dental

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813034583·K-Type Files 21MM #15-40

    DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EDLENi Intra-Oral Sensor

    FDA 510(k)
    FDA Class 2 ·Dental

    BARD STONE BASKET

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC.·Product code FFL·November 26, 2008

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    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS, INC.·Product code KOD·August 25, 2011

    MISC CORE / SEE COMMENTS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 29, 2013

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024