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

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    CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    NexxZr™ T / D-100-35-NT-A350-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112545·

    ihcDirect® TROP2 Ab, 5mL

    FDA UDI
    NOVODIAX, INC.·00850000596825·Clone R1011

    ihcDirect® TROP2 Ab, 15mL

    FDA UDI
    NOVODIAX, INC.·00850000596832·Clone R1011

    ihcDirect® TROP2 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934826·Clone R1011

    ihcDirect® TROP2 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934819·R1011

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·February 9, 2023

    X-PROT DUO PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELECSYS DIGOXIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·March 30, 2023

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·October 12, 2023

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 29, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTE·June 16, 2011

    UNKNOWN PRODUCT - HEMISPHERICAL ACETABULAR CUP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code KWB·August 21, 2008

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 12, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 27, 2016

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023