BEUDAMED
    20 results · 25ms · Sources: EU EUDAMED, US FDA

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    CERTAIN PREVAIL DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

    CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013

    NIM-ECLIPSE® PATIENT MODULE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017

    PROBE SPK1004 SURGEON CONTROLLED

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 14, 2015

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    COMPUTER NOTEBOOK (INTERNATIONAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWC·April 11, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 18, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 17, 2008

    CONTROLLER ECLC ECLIPSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

    NIM-ECLIPSE PREAMPLIFIER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 7, 2021

    COMPUTER NOTEBOOK (INTERNATIONAL)

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024