BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    STAR 65

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEN TEK COMFORT FIT NIGHTGUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    RIVA STAR SILVER DIAMINE FLUORIDE

    FDA Adverse Event
    Injury ·SDI LIMITED·Product code LBH·February 13, 2019

    GMK-HINGE FEMORAL COMPONENT SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·July 25, 2022

    GMK REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013

    GREENLIGHT MOXY

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 15, 2011

    HYDRA JAG GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FDE·September 18, 2008

    ELECSYS PROLACTIN ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CFT·February 26, 2021

    Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·June 24, 2015

    AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020