BEUDAMED
    43 results · 26ms · Sources: EU EUDAMED, US FDA

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    BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD NEEDLE PRECISIONGLIDE 21X1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026

    BD NEEDLE PRECISIONGLIDE 21X1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    SENSAR

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·April 2, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 22, 2014

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code DQY·February 25, 2011

    BD NEEDLE PRECISIONGLIDE 21X1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·February 13, 2026

    BD ULTRA FINE¿ PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code FMI·October 29, 2019

    BD NEEDLE PRECISIONGLIDE 21X1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026

    BD NEEDLE PRECISIONGLIDE 21X1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026

    BD NEEDLE PRECISIONGLIDE 21X1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026

    BD NEEDLE PRECISIONGLIDE 21X1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026

    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025