BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    Microstream CO2 NanoPod

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WOLF Thrombectomy System, 14F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENOMARK ULTRA BREAST TISSUE MARKER

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 6, 2014

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 14, 2026

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 3, 2026

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 10, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 23, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 13, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 29, 2025

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 26, 2026

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 26, 2026

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·January 10, 2025

    Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code MKW·August 13, 2010

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JQP·September 22, 2015

    Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·November 19, 2012

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013