BEUDAMED
    71 results · 25ms · 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 ×

    BIOLOX DELTA CERAMIC FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    GMK HINGE FEMUR SIZE 2 RIGHT

    FDA Adverse Event
    Injury ·Product code KRO·September 12, 2014

    OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2

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

    C-REACTIVE PROTEIN (CRP)

    FDA 510(k)
    FDA Class 2 ·Immunology

    GMK HINGE FEMUR SIZE 5 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNAIONAL SA·Product code KRO·August 21, 2014

    GMK HINGE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·September 4, 2025

    GMK HINGE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·May 13, 2026

    GMK HINGE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·December 30, 2025

    GMK-HINGE FIXED TIBIAL TRAY SIZE 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·October 29, 2020

    GMK-HINGE 02.09.0523H FIXED TIBIAL INSERT SIZE 5/23MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·October 6, 2023

    GMK-HINGE FEMORAL COMPONENT SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2019

    GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019

    GMK-HINGE FEMORAL COMPONENT SIZE3 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·December 20, 2021

    GMK HINGE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·May 13, 2026

    GMK-HINGE FIXED TIBIAL INSERT SIZE 3/20MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·September 15, 2020

    GMK-HINGE FEMORAL COMPONENT SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·August 16, 2018

    GMK HINGE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·September 4, 2025

    GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 14, 2021

    GMK HINGE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·December 11, 2024