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

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    U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS

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

    KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2024

    BIOZDX HEMODYNAMIC MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PT2 VARIAN PROTON THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 3, 2014

    LAMITRODE TRIPOLE 16C

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·June 22, 2011

    EDI BZO Uncut Sheet - Cup*, Item No. 160170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025