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

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    RADWORKS

    FDA 510(k)
    FDA Class 2 ·Dental

    HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·Dental

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·July 1, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 10, 2013

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 21, 2010

    UNK AVENIR STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·June 26, 2014

    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