BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    MULTI-MODALITY IMAGE FUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·M7831201870·Basic Endoscopy Procedure Kit

    RII INFRARED EAR THERMOMETER,

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 27, 2002

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·February 23, 2017

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 11, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 8, 2021

    IN00087 CLERMONT FERRAND PH

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DWF·March 7, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 20, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 25, 2014

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 6, 2011

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·February 9, 2021

    INSPIRE 6F HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 11, 2010

    Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT 84065. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code LRO·August 15, 2007

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    FDA Enforcement
    Class II ·Ongoing·Isopure Corp·July 20, 2022

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020