BEUDAMED
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    ACUMED

    FDA UDI
    Acumed LLC·10806378068959·1.5 mm Solid Hex Driver

    HDF Assist Mudule, HDF Infusion Set and Substitution Filter

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

    RENAFLO HDF 1350 HEMODIAFILTER

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

    5008X HDF Hemodialysis Blood Tubing Set

    FDA UDI
    Fresenius Medical Care Renal Therapies Group, LLC·00840861102365·

    NIPRO ELISIO-H DIALYZER

    FDA Adverse Event
    Injury ·NIPRO CORPORATION (ODT)·Product code KDI·October 25, 2022

    NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER

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

    HDF3500 AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 30, 2020

    HDF3500 AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 26, 2020

    NIPRO ELISIO-H DIALYZER

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION (ODT)·Product code KDI·April 15, 2024

    NIPRO ELISIO H DIALYZER

    FDA Adverse Event
    Malfunction ·NIPRO CORPORATION (ODT)·Product code KDI·May 7, 2025

    5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·June 25, 2025

    HDF3500 AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 2, 2020

    NIPRO ELISIO-H DIALYZER

    FDA Adverse Event
    Injury ·NIPRO CORPORATION (ODT)·Product code KDI·October 15, 2025

    HDF3500 AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 26, 2020

    5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 29, 2025

    HDF3500 AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 6, 2020

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·February 23, 2021

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·February 23, 2021

    HDF3500 AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 26, 2020

    HDF3500 AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 26, 2020