BEUDAMED
    1,752 results · 27ms · Sources: EU EUDAMED, US FDA

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    iGO

    FDA UDI
    Align Technology, Inc.·00816063020486·Sequential Aligner

    Devilbiss iGO

    FDA UDI
    DEVILBISS HEALTHCARE LLC·00885304002277·Portable Oxygen Conentrator

    iGO Plus

    FDA UDI
    Align Technology, Inc.·00816063020479·Sequential Aligner

    QardioArm

    FDA UDI
    QARDIO, INC.·00854894005067·

    i-Go MED (SC21)

    FDA UDI
    Pride Mobility Products Corp·00606509300742·A motorized three-wheeled vehicle is a gasoline...

    INSERTION GAIN OPTIMIZER IGO-1000

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

    MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM

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

    Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include: 1) Autoverify results directly from analyzers and reference laboratories 2) Track tubes and containers from order to final disposition 3) Monitor key metrics such as turnaround time and utilization using management reports 4) Produce pathology results with Structured Reports 5) Suggest microbiology workups online according to defined SOPs and rules 6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools 7) Any change to patient results (inquiry, reports) is logged and available for review

    FDA Recall
    Terminated ·Sunquest Information Systems, Inc.·Product code JQP·April 17, 2008

    TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT50CT

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·February 12, 2024

    PACEMAKER

    FDA Adverse Event
    Other ·Product code DXY·April 11, 2011

    TAMPAXTAMPONSPEARLFULLSIZEREGNORUNSCNT

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·November 5, 2025

    DEPUY PINNACLE ACETABULAR CUP SYSTEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 25, 2013

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·December 19, 2014

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011

    TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT18CT

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·January 9, 2025

    L.TAMPONSORGCOTTONCOMPAKREGNORNONDO

    FDA Adverse Event
    Injury ·ONTEX HYGIENEARTIKEL GMBH·Product code HEB·March 19, 2021

    iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.

    FDA Enforcement
    Class I ·Ongoing·Medical Depot Inc.·May 21, 2025

    TAMPAXTAMPONSPEARLFULLSIZESUPERUNSCNT

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·December 9, 2025

    TAMPAXTAMPONSPEARLFULLSIZESUPERPLUSUNSCNT

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·December 9, 2025