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

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    DDRCOMBI TRAUMA

    FDA 510(k)
    FDA Class 2 ·Radiology

    CPR Bag Reusable

    FDA UDI
    MERCURY ENTERPRISES, INC.·30641043507180·

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756045902·Esophageal Stethoscope w/Temperature Sensor

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013

    FLEXI-SITE SP02 EAR SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHROMOSTREAK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NIM-ECLIPSE® ELECTRODE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016

    NIM-ECLIPSE® ELECTRODE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 10, 2013

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    DIGITAL PREAMPLIFIER

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

    CONTROLLER ECLC ECLIPSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

    IPC® HANDPIECE - STYLUS TOUCH®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Recall
    Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015