BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613072766·Adson Tissue Forceps, 1 X 2 Teeth, Cross Serrat...

    BTL-703-2

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLIDEWELL HT IMPLANT Ø4.3 X 11.5 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 28, 2025

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 4, 2008

    MITY VAC

    FDA Adverse Event
    Injury ·COOPER SURGICAL·Product code HDB·August 17, 2011

    ATLAS PLUS HF CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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