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

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    All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AMERICAN CATHETER, MODEL W3

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WINX SLEEP THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 13, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 16, 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

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025