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

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    MONOCLONAL MOUSE ANTI-HUMAN B-CELL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ENDOASSIST

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

    Elecsys Estradiol III Calcheck

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEARTSTART SLA BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DQA·December 13, 2012

    HERCULITE ULTRA

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EBF·December 31, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 18, 2014

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·March 12, 2025

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·March 12, 2025

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·March 12, 2025

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·March 12, 2025

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015