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

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    FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIRECT BILIRUBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    18" (46 CM) APPX 5.1 ML, EXT SET W/0. CLAMP

    FDA Adverse Event
    ICU MEDICAL INC.·Product code FPA·March 5, 2021

    CARDIOHELP-I

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·September 9, 2020

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·March 26, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 17, 2011

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, INC.·Product code GDW·March 14, 2008

    HEART LUNG MACHINE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·January 22, 2021

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·April 26, 2022

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·June 23, 2022

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·May 4, 2022

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·August 31, 2023

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·December 1, 2021

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·January 13, 2023

    HEART LUNG MACHINE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·February 23, 2024

    MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·October 27, 2022

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·December 7, 2023

    CARDIOHELP

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTQ·December 14, 2023

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024