BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    ADR-2000 AMBULATORY DATA RECORDING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    3 CCD ENDOCAM 5550

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KARL STORZ New Generation Trocars

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 18, 2014

    VENTILATOR, CONTINUOUS, FACILITY USE

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 5, 2010

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·December 14, 2012

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020