BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    ORTHOHELIX SYNDESMOSIS FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PM-8000 PATIENT MONITOR, MODEL 8000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    R3

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·May 29, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 17, 2011

    PROGRAMMING SOFRWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 22, 2008

    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

    FDA Enforcement
    Class II ·Terminated·Neurotherm, Inc.·April 20, 2016