BEUDAMED
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    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749064667·CERAMO TRADITION X bayo. punch fl.foot, 3x140mm...

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    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749064605·CERAMO punch w.ejec. flat foot calibrated, 40° ...

    NA

    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749064599·CERAMO punch w. ejec. flatfoot APART,cali 40° u...

    NA

    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749064612·CERAMO TRADITON X punch fl.ft,calib.40° upw. 2....

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    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749064650·CERAMO bayonet punch w.eject. fl.foot, 3x140mm ...

    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.

    FDA Enforcement
    Class II ·Terminated·Neuronetrix Solutions, LLC dba Cognision·December 18, 2019

    ROCHESTER MEC WIDEBAND M 30BX

    FDA Adverse Event
    Injury ·ROCHESTER MEDICAL CORP 2130787·Product code NNX·October 14, 2016

    ROCHESTER MEC ULTRAFLEX M 30BX

    FDA Adverse Event
    Malfunction ·ROCHESTER MEDICAL CORP 2130787·Product code NNX·November 17, 2016

    ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·November 3, 2017

    ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 30BX

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·December 21, 2017

    ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·November 20, 2017

    ROCHESTER MEC WIDEBAND M 100BX

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·December 26, 2017

    ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·December 22, 2017

    ROCHESTER MEC ULTRAFLEX M 30BX

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·December 12, 2017

    SPIRIT HYDROCOLLOID ADHESIVE SHEATH

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·June 1, 2021

    ULTRAFLEX SELF-ADHERING MALE EXTERNAL CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST HUNGARY·Product code NNX·April 21, 2021

    BARD WOVEN URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·May 10, 2021

    MALE EXTERNAL CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·April 13, 2021

    MALE EXTERNAL CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·June 2, 2021

    SPIRIT HYDROCOLLOID ADHESIVE SHEATH

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code NNX·April 2, 2021