BEUDAMED
    33 results · 24ms · Sources: EU EUDAMED, US FDA

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    PALACOS fast R+G

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2008® Series Hemodialysis Machines

    FDA UDI
    Fresenius Usa, Inc.·00840861100910·2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528103692·7.0 x 65mm Cannulated Screw, 32mm Thd

    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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528108055·7.0 x 65mm Cann Screw 32Thd Sterile 2Pk

    IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    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

    HEARTLIGHT

    FDA Adverse Event
    Injury ·CARDIOFOCUS·Product code OAE·December 6, 2019

    HEARTLIGHT

    FDA Adverse Event
    Injury ·CARDIOFOCUS·Product code OAE·December 6, 2019

    HEARTLIGHT

    FDA Adverse Event
    Injury ·CARDIOFOCUS·Product code DRA·December 6, 2019

    HARMONIC ACE 23 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·October 7, 2008

    ISPAN PERFLUOROPROPANE (C3F8) GAS

    FDA Adverse Event
    Malfunction ·ALCON - FORT WORTH/ ALCON LABORATORIES INC.·Product code LPO·June 24, 2013

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 26, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 6, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 15, 2020

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·February 9, 2023

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·December 6, 2024

    2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·March 7, 2018