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

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    TACAMO MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Q-LUX PLASMA 100 LIGHT CURE UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    PLUS CANCELLOUS BONE SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·December 14, 2021

    CADD ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·January 11, 2022

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·December 28, 2021

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    VA-LCP-2-COLUMN DRP2.4 VOLAR LE SHAFT 2H

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·May 9, 2013

    APEX HIP SYSTEM

    FDA Adverse Event
    Injury ·OMNLIFE SCIENCE INC.·Product code LPH·August 28, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 11, 2011

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012