BEUDAMED
    11 results · 37ms · Sources: EU EUDAMED, US FDA

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    MESIRE - Balloon Sinus Dilatation System

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    BD ALLERGY SYRINGE TRAY 1ML 27G X 1/2 IN BD PRECISIONGLIDE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 25, 2019

    KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CSCS-001A CALCIUM SCORING PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 18, 2024

    BD MICRO FINE PLUS ¿ PEN INJECTOR NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 22, 2018

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 22, 2011

    TRIDENT 10° X3 INSERT 28MM ID

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·June 17, 2013

    UVSL COMMAND MODULE

    FDA Adverse Event
    Malfunction ·SPACELABS MEDICAL·Product code MHX·September 22, 2008

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020