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

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    Glidewire GT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026

    RADIFOCUS GLIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025

    TERUMO RADIFOCUS GUIDE WIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025

    GLIDEWIRE GT

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003449·MCK PATELLOFEMORAL TRIAL (7 RIGHT)

    XKNIFE 5

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 20, 2019

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·June 14, 2013

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 20, 2011

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·May 3, 2017

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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