BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD POSIFLUSH¿ SURESCRUB¿ SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 26, 2023

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 7, 2023

    ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PEFAKIT APC-R FACTOR V LEIDEN CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYRINGE 10ML REG PR SALINE 10ML FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·October 20, 2023

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·September 28, 2023

    SYRINGE 10ML REG PR SALINE 10ML FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·November 30, 2023

    SYRINGE 10ML REG PR SALINE 10ML FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·October 17, 2023

    CASHMERE 14 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·June 3, 2013

    ARTICUL/EZE BALL 32 +5 BR

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code JDI·June 23, 2011

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 27, 2008

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·September 28, 2023

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·September 28, 2023

    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025