BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741163289·Catheter Placement Kit

    Preat

    FDA UDI
    Preat Corporation·00842092170618·ASC NobelActive™/Conical-compatible NP X 9mm En...

    FlowLogic Assert

    FDA UDI
    SONENDO, INC.·00810209421335·FlowLogic Assert Shaping File 25 Variable, 31mm

    COMPUMEDICS E-SERIES EEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Alteon

    FDA UDI
    Exactech, Inc.·10885862555731·ALT CUP TRL G8 SIZE 68

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL, INC.·Product code FAD·February 17, 2011

    9600+

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 21, 2008

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·June 17, 2022

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    FDA Adverse Event
    Malfunction ·LUMIRADX UK LTD.·Product code QKP·June 17, 2022

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 6, 2020

    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Recall
    Terminated ·ZOLL Circulation, Inc.·Product code NCX·August 6, 2021

    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·October 13, 2021

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024