BEUDAMED
    9 results · 33ms · Sources: EU EUDAMED, US FDA

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    PERIO/ENDO LENS

    FDA 510(k)
    FDA Class 1 ·Dental

    GAMMA3 NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    6MP COLOR LCD MONITOR, RADIFORCE RX650

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 8, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·August 8, 2024

    MEDI-LAB PERFORMANCE HCG COMBO TEST-CASSETTE

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·December 1, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 30, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 3, 2014

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021