BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    BIOPSER

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707028000·WEB 1ST MOLAR BANDS n.UR 19

    Erchonia Zerona Z-Bed

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

    HEARTWATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PURITAN BENNET

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·May 15, 2014

    PDL IMPLANT

    FDA Adverse Event
    Injury ·Product code MJO·November 6, 2012

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·August 31, 2010

    icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·April 24, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021