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

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    Electronic Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMR 3-PEGS GLENOIDS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEFLECTING URETERAL ACCESS SHEATH

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

    COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 17, 2008

    SPECTRANETICS LASER SHEATH II

    FDA Adverse Event
    Injury ·SPECTRANETICS CORP·Product code MFA·August 12, 2011

    TOTAL ASR FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 16, 2013

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025

    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