BEUDAMED
    18 results · 30ms · Sources: EU EUDAMED, US FDA

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    SYSMEX MODEL UF1000I

    FDA 510(k)
    FDA Class 2 ·Hematology

    R3ACT Stabilization System

    FDA UDI
    Paragon 28, Inc.·00889795113740·Ø0.90mm Drill Point K-Wire

    MEDICON YASARGIL CLIP APPLYING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF

    FDA 510(k)
    FDA Class 2 ·Neurology

    COULTER SCATTER PAK REAGENT KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER AUSTRALIA PTY LTD·Product code GGK·October 7, 2011

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/12MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·April 22, 2013

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 27, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·July 3, 2008

    EPSILA EV¿ MRI SURESCAN¿

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·August 28, 2024

    CAPSURE SENSE LEAD MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 13, 2025

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·October 4, 2012

    SPRINT QUATTRO LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO VILLALBA·Product code LWS·November 7, 2025

    THE ELECTRODE STORE

    FDA Adverse Event
    Malfunction ·THE ELECTRODE STORE·Product code GXZ·July 17, 2021

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    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

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017