BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    MICRODOSE SI

    FDA 510(k)
    FDA Class 2 ·Radiology

    Instruments for Revision Surgery

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575033546·Bone Cement Gouge, Stainless Steel, Version= st...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857560857·Forward Angled Curette Size #4

    IBD-QUIK CHEK

    FDA 510(k)
    FDA Class 1 ·Immunology

    ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013

    AUTOPULSE® LIFEBAND

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code DRM·September 30, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·June 16, 2011

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 3, 2013

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 28, 2014

    ADULT DUAL HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 28, 2013

    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014

    MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 9896 001 41502

    FDA Recall
    Terminated ·Philips Medical Systems Sales & Service Region No. America·Product code IZI·June 8, 2004

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019