BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    SALVATION BEAMS AND BOLTS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ForPro

    FDA UDI
    Tng Worldwide, Inc.·00672047000932·Black Nitrile Exam Glove Size Small 1000ct

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925035478·Trapeze Ribbon Loop 4.0 mm Length Platinum

    ULTRASOUND LOCALIZATION SYSTEM ULS 0142

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

    REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2013

    LINOX T 65

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·June 15, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 3, 2014

    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