BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CASPIAN SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·December 21, 2018

    PKAPPA/CD23/CD19/CD5/CD38/45 CTT LYO CM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code MVU·January 21, 2021

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·May 29, 2019

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 28, 2019

    1030489-2019-01511

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·December 31, 2019

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 11, 2013

    GLOBAL ADVANTAGE HUM HD 40X15

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.·Product code KWT·July 8, 2011

    ADVIA CENTAUR TOTAL HCG (THCG)

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHI·September 15, 2008

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·September 8, 2021

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 22, 2022

    KYPHON XPEDE BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 16, 2020

    ARCHITECT IPTH REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code CEW·March 19, 2025

    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