BEUDAMED
    22 results · 31ms · Sources: EU EUDAMED, US FDA

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    FlexSeal Introducer Sheath with Hydrophilic Coating

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017880·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017958·K-Wire, Double Ended, Trocar Point, Diameter 0....

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319741689·Adson Suction Tube 8" (20cm), with finger valve...

    PLASMALUXLS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 1, 2024

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 6, 2008

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 26, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 22, 2011

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    MEDLINE 120 MINI URINE ANALYZER

    FDA Adverse Event
    Malfunction ·ACON LABORATORIES, INC.·Product code KQO·September 22, 2023

    TOWEL OR 17X24IN BLUE STERILE 4/PK

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH SHANGHAI·Product code FRL·January 22, 2020

    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 Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015

    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