BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    FOIL BABY BUNTING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Base Long For Drapelink

    FDA UDI
    Brainlab SE·04056481004514·

    ABUTMENT GLO

    FDA 510(k)
    FDA Class 1 ·Dental

    SYSNPAR PORCELAIN

    FDA 510(k)
    FDA Class 2 ·Dental

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·May 28, 2014

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·December 19, 2012

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC·Product code NDN·November 2, 2010

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025