BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    IPS CERAMIC ETCHING GEL

    FDA 510(k)
    FDA Class 2 ·Dental

    METASURG NITINOL STAPLE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 22, 2013

    DEPUY ASR XL FEM IMP SZ 49

    FDA Adverse Event
    Injury ·DEPUY INTL LTD·Product code KXA·December 8, 2010

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014

    IMMULITE 2000 ESTRADIOL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024

    UNKNOWN MINI ANCHOR

    FDA Adverse Event
    Injury ·DEPUY MITEK LLC US·Product code HWC·September 30, 2019

    IMMULITE 2000 ESTRADIOL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024

    IMMULITE 2000 ESTRADIOL

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024

    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O 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