BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Reprocessed Kendall SCD Express Foot Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VS-800 VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

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

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 23, 2021

    DEPTH ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    TRAY F/MINI-SCR W/LID

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code FSM·June 11, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·July 15, 2011

    COROX OTW-S 85-BP

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

    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

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014