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

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    TENURE4G

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257141663·20-30 MFW VITALITY CALF CT EBONY VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257127063·20-30 MV FOR MEN SEL CALF STD BLK VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125359·20-30 MV FOR MEN CLSC CALF STD BLACK VII

    Obwegeser Thread Knotting Forceps

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896118508·Obwegeser Thread Knotting Forceps With Double S...

    AMS APOGEE VAULT SUSPENSION SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE

    FDA 510(k)
    FDA Unclassified ·Unknown

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 20, 2021

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 31, 2013

    MYNX

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·June 21, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 28, 2008

    GALAFLEX

    FDA Adverse Event
    Injury ·TEPHA, INC·Product code OOD·February 28, 2020

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019