BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    RedPoint Medical's Better Bunion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EBV V VCA IGM ELISA KIT MODEL# EBM-200

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 23, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

    SPECTRUM IQ INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022

    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