BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    PULPDENT PIC N STIC

    FDA 510(k)
    FDA Class 1 ·Dental

    Omni Hysteroscope, Omni Lok cervical seal

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INTUITIVE SURGICAL ULTRASONIC SHEARS

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

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 31, 2025

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 11, 2012

    ACIST

    FDA Adverse Event
    Injury ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·November 23, 2010

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 2, 2014