BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology

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

    CHIMAERA HIP FRACTURE SYSTEM

    FDA UDI
    ORTHOFIX SRL·18054242515562·LAG SCREW TROCAR

    OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CASPIAN SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS PCA MDULE

    FDA Adverse Event
    Other ·CARDINAL HEALTH ALARIS PRODUCTS·Product code MEA·October 6, 2008

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 25, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

    LASSOSTARNAV,10P,15MM DIA LOOP

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023

    LASSOSTAR CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020

    WALLSTENT? RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

    LASSOSTAR NAV CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 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