BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    TABATABA COTESTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450182741·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450198094·

    SAUFLON MULTIPURPOSE SOLUTION - NO RUB

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VIVANT MEDICAL BIOPSY MARKER SYSTEM

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

    RD SET YI

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    M-LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·November 21, 2016

    RADICAL-7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·February 19, 2016

    RAD-57 CONFIGURABLE PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·June 24, 2019

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·April 24, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011

    WECK DISPOSABLE ELECTRODE IMA/ENT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GEI·July 22, 2008

    RAINBOW RC-4

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 11, 2017

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    RD SET

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025

    ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·December 11, 2017

    ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·December 11, 2017

    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015