BEUDAMED
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    Vantage Titan 3T, MRT-3010, V2.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    2008T BlueStar Hemodialysis Machine

    FDA UDI
    Fresenius Medical Care Holdings, Inc.·00840861102105·

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331184697·Yasargil Micro Bipolar Bayonet Forceps, flat ha...

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 12, 2002

    BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LABONACHECK A1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·June 26, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 25, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LKK·September 26, 2008

    2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 17, 2024

    2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·May 29, 2024

    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

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

    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·August 8, 2024

    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·September 18, 2024

    2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)

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

    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·March 12, 2020

    2008T HD SYS. W/O CDX BLUESTAR

    FDA Enforcement
    Class I ·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023