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

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    ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GIRAFFE2

    FDA 510(k)
    FDA Unclassified ·Unknown

    DRY LASER IMAGER, MODEL DRYPRO MODEL 793

    FDA 510(k)
    FDA Class 2 ·Radiology

    BMT GB KNEE STM 12X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 26, 2020

    ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FTL·May 29, 2013

    POLYURETHANE, FLEXIBLE BRAIDED, TUBING

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTR·May 26, 2011

    PROTÉGÉ MRI IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code GZB·October 9, 2015

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    VIDAS TSH

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 25, 2020

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·August 19, 2021

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021