BEUDAMED
    29 results · 28ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964003927·The ENDO CARRY-ON Procedure Kit contains all of...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040179307·Diamond Discs mounted

    NIGHTTIME ALIGNERS-MCC

    FDA UDI
    Access Dental Lab, LLC·00850007728311·MID-COURSE CORRECTION

    Zavation

    FDA UDI
    Zavation LLC·00842166122109·3-Level, 63mm Cervical Plate

    ACCESS DENTAL LAB

    FDA UDI
    Access Dental Lab, LLC·00850007728120·NIGHTTIME CLEAR ALIGNERS-MIDCOURSE CORRECTIONS

    CURE™ ACP

    FDA UDI
    MEDITECH SPINE, LLC·B167700003630·

    CURE ACP

    FDA UDI
    SpineArt SA·07640375233332·ANTERIOR CERVICAL PLATE, 3 LEVELS L63

    FlowLogic Agile

    FDA UDI
    SONENDO, INC.·00810209421083·FlowLogic Agile Shaping File 10 Variable, 31mm

    CURE™ ACP

    FDA UDI
    MEDITECH SPINE, LLC·B167S1700003630·

    GO MEDICAL BALLOON INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PM 2002 PROLINE/AEC

    FDA 510(k)
    FDA Class 2 ·Dental

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·June 23, 2025

    SENSAR IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·February 18, 2025

    ON-Q PUMP WITH SELECT-A-FLOW

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL - IRVINE·Product code MEB·February 20, 2020

    TAXUS® LIBERTÉ® ATOM¿

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 12, 2013

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 18, 2011

    GE VINGMED

    FDA Adverse Event
    Malfunction ·GE·Product code IYO·February 15, 2008

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012