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

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    Orthoscan TAU Mini C-Arm

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464089574·HEARLINK 1700 BTE PP BR/TP

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209124·Needle Hder with Aial Handle

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180136342·5MM, 32CM NEEDLE HOLDER, CURVED RIGHT TUNGSTEN ...

    Cortex Laser System

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

    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINOX SMART PROMRI S 65

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·November 14, 2014

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 16, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 26, 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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013