BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    CRYOCHECK WEAK LUPUS POSITIVE CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032804·Baltic Denture System BDLoad Mn7 PLSEbim6DFm A3...

    Trilogy

    FDA UDI
    Respironics, Inc.·00606959025370·Trilogy 200 Ventilator, Japan

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425493524·DRESSING TRAY

    N PROTEIN STANDARD SL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 9, 2016

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    FDA Adverse Event
    Injury ·Product code JWH·October 16, 2013

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 30, 2016

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·December 29, 2016

    AMINGO

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 4, 2017

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    FDA Adverse Event
    APPLIED MEDICAL·Product code GDO·March 25, 2013

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 29, 2011

    REZOOM

    FDA Adverse Event
    Injury ·A.M.O.·Product code HQL·April 21, 2008

    EDWARDS INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025

    EDWARDS INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025

    EDWARDS INFLATION DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022

    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

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

    Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·March 30, 2022

    Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JJE·December 15, 2003