BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    Wellead® Latex Foley Catheter

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

    CERTEX OCT SPINAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    200 MICRON TFL SINGLE USE FIBER

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·February 15, 2023

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 18, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    INVACARE CLEVELAND STREET·Product code BTI·July 18, 2013

    SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code GEX·February 15, 2023

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

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