BEUDAMED
    21 results · 37ms · Sources: EU EUDAMED, US FDA

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    GEM PREMIER 4000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TALON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLATEK SHEET

    FDA 510(k)
    FDA Unclassified ·Unknown

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

    CRE? WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013

    AUTOPULSE LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 15, 2013

    EVERA MRI SR

    FDA Adverse Event
    Death ·IPG MFG SWITZERLAND·Product code LWS·September 24, 2014

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012

    LOGIC CC TIB INSERT SIZE 1, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 25, 2024

    CRE? WIREGUIDED

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·December 5, 2012

    CRE¿ WIREGUIDED

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 2, 2012

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    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