BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    Arthrex Spine Compression FT Screw

    FDA 510(k)
    FDA Unclassified ·Unknown

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464093830·HEARLINK 1500 MNR T DG

    Healing Abutment

    FDA UDI
    BICON, LLC·00813110022066·5.0 x 4.0mm Healing Abutment - 2.5mm Post

    truFreeze System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CZR PRESS LF STAINS

    FDA 510(k)
    FDA Class 2 ·Dental

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 30, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 14, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·July 29, 2013

    MAVERIC MEDICAL LLC

    FDA Adverse Event
    Malfunction ·ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.·Product code JKA·April 14, 2026

    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