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

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    ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011188·Zirlux 16+ A1 95X10

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 12, 2013

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 12, 2014

    MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2025

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 18, 2025

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·June 25, 2015

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 18, 2016

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN (IRVINE)·Product code OUT·June 25, 2015

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·March 19, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 15, 2014

    SEQUOIA

    FDA Adverse Event
    Malfunction ·ABBOTT SPINE·Product code HXX·March 10, 2008

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018