BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    Reprocessed Covidien Trocar

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

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10887488580609·APOLOGY PACK

    PRISMAFLEX SYSTEM, VERSION 3.20

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

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 3, 2025

    PRISMAFLEX

    FDA Adverse Event
    Injury ·GAMBRO LUNDIA AB·Product code KDI·October 7, 2010

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 15, 2011

    PROTEUS XR/A

    FDA Adverse Event
    Malfunction ·GE HANGWEI MEDICAL SYSTEMS CO., LTD.·Product code KPR·September 18, 2008

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

    FDA Enforcement
    Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022