BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    MULTIX Impact

    FDA 510(k)
    FDA Class 2 ·Radiology

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G586G1825170·selman tissue forceps, round jaws w/ teeth, 6" ...

    ULTRASEAL XT HYDRO

    FDA 510(k)
    FDA Class 2 ·Dental

    TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS

    FDA 510(k)
    FDA Class 1 ·Dental

    BD VACUTAINER® CPTTM GLASS TUBE WITH BLUE/BLACK SPECKLED CONVENTIONAL CLOSURE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·November 27, 2017

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 11, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 19, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023

    COMPR NANO HMRL PPS 34MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024

    COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024

    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