BEUDAMED
    9 results · 34ms · Sources: EU EUDAMED, US FDA

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    ALGINATE FIBER TOPICAL WOUND DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AXSOS

    FDA UDI
    Stryker GmbH·07613327087826·Tag Titanium 4.0mm Screws

    ELECSYS CK-MB STAT IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEARTSTART MRX, MODEL M3535A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OPERATING CYSTOSCOPE-URETHROSCOPE

    FDA Adverse Event
    Death ·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·April 17, 2014

    OP-1 IMPLANT (EPTOTERMIN ALFA)

    FDA Adverse Event
    Injury ·STRYKER BIOTECH·Product code MPY·December 20, 2010

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 3, 2013

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020