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

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    Anovo Surgical System (6Ne)

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

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464089949·HEARLINK 1700 BTE PP BL/DG DEMO

    Besmed Reusable Jet Nebulizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 14, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·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