BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EarQ

    FDA UDI
    Oticon A/S·05707131343154·G20, MINIRITE 312 2.4G C093 EARQ

    ASICO SOFTIP INJECTOR SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code OVD·November 13, 2019

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·October 7, 2008

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·July 21, 2011

    M2A-MAGNUM MODULAR HEAD SIZE 54MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

    ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·April 23, 2019

    ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·January 27, 2023

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

    ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·May 13, 2023

    DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·July 10, 2019

    Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

    FDA Enforcement
    Class II ·Terminated·Thoratec Corp.·May 1, 2019