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

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    Aer-O-Scope Colonoscope System

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

    ARTEGRAL AND POLYSTAR SELECTION

    FDA 510(k)
    FDA Class 2 ·Dental

    MERIT HYDROPHILIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMP TM 3.7MM MTX,11.5MM

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·December 1, 2025

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 6, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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