BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS

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

    COFLEX-F

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDISTIM VERIQC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·April 13, 2015

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·May 1, 2013

    SONICATOR PLUS 994

    FDA Adverse Event
    METTLER ELECTRONICS CORP·Product code IMG·June 3, 2011

    INTERSTIM II

    FDA Adverse Event
    Injury ·MPROC, JUNCOS·Product code EZW·August 22, 2008

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·July 12, 2016

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023