BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103111·BENEDETTO INTRALASE SPATULA

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517075519·

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523167012·Initia Acetabular Standard Liner, E-CIMA 32-52/54

    TECRES SPACER-K TEMPORARY KNEE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·April 13, 2015

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·October 1, 2014

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·May 1, 2013

    COULTER® LH 750

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 17, 2011

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·July 12, 2016

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015