BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIO-MODULAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304443044·

    5530 3L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00817136024486·iCardiac 3L SYRINGE 5530

    SIGNATURE PLANNER,SIGNATURE GUIDES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRYSTAL MONITOR MODEL 16

    FDA 510(k)
    FDA Class 2 ·Neurology

    ATTUNE CR FEM RT SZ 4 CEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code JWH·November 4, 2019

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    HUDSON OPTI-NEB PRO COMPRESSOR W/ DISP. NEB.

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code CAF·May 7, 2013

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 17, 2011

    9617604-2008-00064

    FDA Adverse Event
    Malfunction ·Product code FPA·May 23, 2008

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code MBF·August 21, 2019

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024