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

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    ARiX RAD Radiographic System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bernafon

    FDA UDI
    Bernafon AG·05711584078648·AQ CO9 MNR T, 2.4G NFM DPB SABE/MSIL ACCUQ

    PROPELLER HEAD SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304269477·

    MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CIRCULATOR BOOT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 17, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 14, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 28, 2011

    SOMATICS THYMATRON SYSTEM IV

    FDA Adverse Event
    Injury ·SOMATICS, LLC·Product code GXC·September 8, 2022

    ECT DEVICE

    FDA Adverse Event
    Injury ·SOMATICS, LLC·Product code QGH·August 8, 2022

    2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015