BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517639240·CoRoent Ant TLIF PEEK, 9x10x28mm 12°

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017880·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721193·Buck Ear Curette 6-1/2" (16.3cm), size 1, blunt...

    Sierra Summit/Ascent

    FDA UDI
    CADWELL INDUSTRIES, INC.·00840067100110·Summit Tendon Hammer

    TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QMS LIDOCAINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD SOLOMED SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·October 15, 2020

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·October 21, 2014

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    TEGADERM CHG DRESSING

    FDA Adverse Event
    Injury ·3M HEALTH CARE·Product code FRO·July 25, 2011

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

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