BEUDAMED
    24 results · 24ms · Sources: EU EUDAMED, US FDA

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    Surgify Halo

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAYCELL

    FDA 510(k)
    FDA Unclassified ·Unknown

    GMK TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024

    GMK TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023

    MCKESSON MEDI-LAB HCG URINE CASSETTE

    FDA Adverse Event
    Malfunction ·INNOVACON, INC.·Product code JHI·November 13, 2008

    UNK DEPUY ASR 50 CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011

    HERO

    FDA Adverse Event
    Injury ·HEMOSPHERE, INC.·Product code DSY·July 18, 2013

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 4, 2024

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2024

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 13, 2024

    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

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 19, 2023

    GMK TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2025

    GMK TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 22, 2024