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

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    SYNTHOGRAFT

    FDA 510(k)
    FDA Class 2 ·Dental

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496051091·MARLENE POIS 70, SIZE S, MOSTO, GRADUATED COMPR...

    CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DREAMSTATION AUTO BIPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 28, 2022

    CONCERTO CRT-D DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 10, 2013

    ATOMIC ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·SPINAL ELEMENTS, INC.·Product code KWQ·May 22, 2008

    CONTINUUM LONGEVITY CROSSLINKED POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·April 5, 2011

    BD FACS 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

    HENRY SCHEIN

    FDA Adverse Event
    Malfunction ·A.R. MEDICOM INC. (SHANGHAI) LTD.·Product code FXX·December 12, 2016

    HENRY SCHEIN SOFT EARLOOP FACE MASK

    FDA Adverse Event
    Other ·A.R. MEDICOM·Product code FXX·July 27, 2012

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022