BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ESTECEM

    FDA 510(k)
    FDA Class 2 ·Dental

    AUVON TENS & EMS DEVICE

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

    THERMOPHORE ARTHRITIS PAD

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·December 1, 2008

    UNK INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·September 12, 2011

    LYSONIX BULLET TIP 5MM30CM PROBE

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code MUU·July 19, 2013

    AUVON TENS UNIT

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

    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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013