BEUDAMED
    19 results · 32ms · Sources: EU EUDAMED, US FDA

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    Brevera Biopsy System with Corlumina Imaging Technology

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

    LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES

    FDA 510(k)
    FDA Class 2 ·Dental

    V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KYPHON XPEDE BONE CEMENT

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

    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

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·October 16, 2024

    1030489-2019-01511

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

    HOLD-SL W/LOCK F/PEDIC SCR CLICKX STANDA

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code MNI·June 11, 2013

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 15, 2011

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.,·Product code DTB·September 12, 2008

    1030489-2019-01423

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

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    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

    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