BEUDAMED
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    F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    2008® Series Hemodialysis Machines

    FDA UDI
    Fresenius Usa, Inc.·00840861100897·2008T HEMODIALYSIS SYS., with CDX

    2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·December 28, 2022

    ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    WATERPAP VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·April 6, 2023

    2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·July 27, 2022

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·October 6, 2008

    PLV-102

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 24, 2013

    ISOLINE

    FDA Adverse Event
    Injury ·SORIN CRM·Product code MRM·July 26, 2011

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 2, 2022

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 21, 2014

    VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.

    FDA Enforcement
    Class III ·Terminated·MICROVENTION INC.·June 16, 2021

    Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·April 29, 2020

    Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·January 19, 2011

    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 25, 2014

    2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·July 13, 2018

    2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·September 26, 2018