BEUDAMED
    30 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    GMK SHORT STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019

    GMK SPHERE FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 11, 2020

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2020

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2020

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2019

    3005180920-2018-00587

    FDA Adverse Event
    Injury ·July 31, 2018

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 13, 2017

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 15, 2024

    GMK SPHERE TOTAL KNEE SYSTEM

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

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2025

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2019

    GMK PRIMARY CEMENTED NARROW FEMUR SIZE 4 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 27, 2015

    Black Silicone

    FDA UDI
    COOK INCORPORATED·00827002151482·Black Silicone Filiform Double Pigtail Ureteral...

    Cook

    FDA UDI
    COOK INCORPORATED·00827002464421·Black Silicone Filiform Double Pigtail Ureteral...

    MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK

    FDA 510(k)
    FDA Class 2 ·Dental