BEUDAMED
    16 results · 31ms · Sources: EU EUDAMED, US FDA

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    Mobius3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450192689·

    KAPPA IMMAGE FREELITE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025

    CLEARLINK CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 22, 2023

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 24, 2022

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 4, 2022

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 24, 2022

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NVZ·August 11, 2011

    7810 VENTILATOR

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA·Product code CBK·October 9, 2008

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·July 3, 2013

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 14, 2022

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012