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

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    RayStation

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACUMED

    FDA UDI
    Acumed LLC·10806378014727·2.7mm x 38.0mm Locking Cortical Screw

    ACUMED

    FDA UDI
    Acumed LLC·10806378014734·2.7mm x 38.0mm Locking Cortical Screw

    MERIT EMBOLECTOMY CATHETER MODEL ASAP100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable SpO2 Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIT DRAIN 100CC W/7MM PERF

    FDA Adverse Event
    Malfunction ·PR006 PUERTO RICO-ANASCO·Product code GCY·May 16, 2023

    X-STOP PEEK INTERSPINOUS SPACER

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NQO·October 24, 2014

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·December 20, 2019

    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

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014