BEUDAMED
    20 results · 32ms · Sources: EU EUDAMED, US FDA

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    OPERATING ROOM TRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482301·PLATE 6860160 60 MM ANTERIOR CERVICAL

    BIS

    FDA UDI
    Covidien LP·20884521657837·Extend Sensor

    MONITOR, PATIENT (MODEL 78333A)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Non-Telescopic PenEvac

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BIS

    FDA Adverse Event
    Malfunction ·CELESTICA ELECTRONICS S PTE LTD·Product code GXY·February 2, 2024

    CORAIL2 STD SIZE 11

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWA·April 2, 2019

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    HEMOVAC BLOOD REINFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code CAC·November 21, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 21, 2010

    PINNACLE SECTOR II CUP 58MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·September 10, 2013

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 15, 2013

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 15, 2013

    CORAIL2 STD SIZE 11

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG. # 30038955·Product code KWA·September 10, 2013

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 20, 2020

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 20, 2020

    CORAIL2 STD SIZE 11

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWA·January 20, 2020

    M2A 38MM MOD HD STD NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 3, 2017

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012