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

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    Kirschner Wires, Steinmann Pins

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T PLATE

    FDA UDI
    Biomet Orthopedics, LLC·00887868004551·

    TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARCORRECT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    INDIGO SYSTEM ASPIRATION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DXE·August 11, 2020

    VALEO / VALEO II

    FDA Adverse Event
    Malfunction ·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 3, 2013

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·October 6, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·June 3, 2011

    INTIMA II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·October 31, 2018

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024