BEUDAMED
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    CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776174576·Cushing Fcps TC with rounded tip

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668103128·MORAN ENHANCEMENT SPATULA DOUBLE ENDED

    FUTURA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ADVIA 60 HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    BELLATEK® ZIRCONIA ABUTMENT

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 1, 2014

    SYNREAM FLEXSHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTO·May 29, 2013

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·June 8, 2011

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·April 25, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·January 4, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FGE·February 18, 2019

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·July 26, 2019

    VANGUARD MONO FINNED STM TIB 71X8

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019