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

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    KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)

    FDA 510(k)
    FDA Class 1 ·Radiology

    DeBakey Derra Anastomosis Clamps

    FDA UDI
    KOROS U.S.A., INC.·10840199540010·DeBakey Derra Anastomosis Clamps Large 16.5cm 6...

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127021466·Number Three Retractor

    X-PAC® LLIF Expandable Lateral Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024207240·

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·February 8, 2013

    VITALITY

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023