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

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    OHMEDA POSI-PULSE SUCTION UNIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    L4 OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NATRELLE

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code FTR·May 29, 2014

    SPACEMAKER BLUNT TIP TROCAR 12MM

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·October 1, 2010

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 2, 2012

    B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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