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

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    U2 Total Knee System-PF+

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL™ Phenol Red Broth with Xylose and Durham Tube

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902217054·BD BBL™ Phenol Red Broth with Xylose and Durham...

    MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    GEO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 15, 2016

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    GALILEO ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·September 30, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 3, 2014

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DENTSPLY PROFESSIONAL·Product code EKX·June 3, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·August 15, 2011

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022