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

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    PRECISION SKIN EMULSION

    FDA 510(k)
    FDA Unclassified ·Unknown

    BiPAP A40

    FDA UDI
    Respironics, Inc.·00606959039469·BiPAP A40 Ventilator, USA

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010038029·CHISEL FOR HTO BLADE STAPLE

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390850490·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390867290·

    LEGEND POWER ADAPTER MODEL: 6475000

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROGEN NERVE GUIDE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·March 26, 2013

    CONTOUR USB

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012

    CONTOUR NEXT

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE LLC·Product code NBW·July 27, 2012

    EON MINI

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code MCX·September 23, 2014

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·May 26, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 24, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 17, 2022

    HAHN TAPERED IMPLANT Ø7.0 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 16, 2023

    A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·July 21, 2021

    Artis Q.zen ceiling, Model Number 10848354

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025