BEUDAMED
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    ANTHRACIS REAL-TIME PCR ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGXO

    FDA UDI
    Oticon A/S·05707131270078·H160, DESIGNRITE 10 WL PLI AGXO

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925014251·SHEA CUP PISTON LARGE, RIGHT 4.5 MM LENGTH FLUO...

    Cancellous Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120034305955·Cancellous Screw, Cannulated, D=4.0mm, L=26mm

    DYNA-EXTOR II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRANS1 AXIAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE 02.07.1204R TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2023

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 29, 2019

    GMK SPHERE IMPLANTS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 4, 2025

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC, CRMD·Product code DXY·January 13, 2014

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·May 31, 2013

    ADJUSTABLE PIN COLLET

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 17, 2011

    GMK-SPHERE 02.07.1206L TIBIAL TRAY FIXED CEMENTED SIZE 6 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 20, 2022

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2021

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 30, 2019

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 30, 2022

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 6, 2025

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 7, 2023

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025

    ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015