BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Allcem Veneer APS

    FDA 510(k)
    FDA Class 2 ·Dental

    JUSHA-C31 MEDICAL DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    EQUALSHIELD LUER LOCK CONNECTOR PAIR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 26, 2013

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 28, 2011

    ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·December 2, 2022

    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·August 8, 2024

    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·September 18, 2024