BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257130124·30-40 MV FOR MEN CLSC EW STD BLACK V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257128572·30-40 MV FOR MEN SEL EW CLF STD BLK V

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015375459·REVISION LOCKING SCREW L57.5MM D4.0MM

    ORTHOFIX

    FDA UDI
    ORTHOFIX SRL·18059015374957·REVISION LOCKING SCREW L57.5MM D4.0MM STERILE

    PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENGSTROM CARESTATION, ENGSTROM PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNKNOWN IMPLANTABLE PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·November 10, 2014

    6875 HANA OPERATING ROOM TABLE

    FDA Adverse Event
    MIZUHO OSI·Product code JEA·August 24, 2011

    TWIST DRILL - 1.5MM X 6MM SCRW

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014