BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    BIOMECHANIC LOW-PROFILE CABLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Rainbow Shade

    FDA 510(k)
    FDA Class 2 ·Dental

    EQUATOR PLUS ACETABULAR CUP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ATTAIN COMMAND

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code DQY·February 9, 2013

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·December 28, 2010

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON LENSX LASERS, INC.·Product code OOE·July 2, 2014

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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