BEUDAMED
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    BIOPLEX 2200 APLS IGM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CrossRoads

    FDA UDI
    Provision·B504OM1305280·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707010760·CALIBRA 1ST MOLAR BANDS n.UL 28

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450699119·

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 24, 2013

    HOMECHOICE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 30, 2014

    UNKNOWN ZIMMER LPS PROLONG ART SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 14, 2011

    CAPIOX®FX

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 19, 2026

    CAPIOX FX25 OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 9, 2022

    CAPIOX®FX

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 30, 2026

    CAPIOX FX25 OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 6, 2025

    CAPIOX FX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 25, 2021

    CAPIOX FX25 OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 18, 2022

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    CAPIOX FX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 11, 2020

    CAPIOX FX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 9, 2024

    CAPIOX FX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 10, 2020