BEUDAMED
    17 results · 31ms · Sources: EU EUDAMED, US FDA

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    Fixone Biocomposite Interference Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EarQ

    FDA UDI
    Oticon A/S·05707131343789·G10, MINIRITE 312 2.4G C090 EARQ

    THD BANDY

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

    CERAMIC FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2025

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 22, 2024

    CONTOUR PLUS ELITE

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 1, 2023

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·October 8, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 5, 2011

    UNKNOWN M2A MAGNUM HIP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013

    TPRLC 133 FP TYPE1 PPS SO 4.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·March 5, 2025

    TPRLC XR T1 PPS 14X148MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·March 5, 2025

    TPRLC XR MP FP T1 PPS 5X95MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·March 5, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 10, 2023

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 23, 2023

    K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·July 10, 2019

    Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

    FDA Enforcement
    Class II ·Terminated·Thoratec Corp.·May 1, 2019