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

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    ENFit enteral syringe

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

    EXPLORER LIVER (PASSIVE TRACKING)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO MYALLERGY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 9, 2024

    TRI W-G, INC. MODEL 630

    FDA Adverse Event
    Malfunction ·TRI W-G, INC·Product code INQ·June 22, 2021

    BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 25, 2021

    BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 25, 2021

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 3, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·July 11, 2011

    MESHGRAFT II COMPLETE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FZW·January 24, 2014

    CUSTOM PACK CB1Q91R6 NTUH CCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code DWE·June 22, 2022

    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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

    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    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; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    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; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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

    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; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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

    Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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

    Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

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