BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES

    FDA 510(k)
    FDA Class 2 ·Hematology

    Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606561·Sprint II Brackets Roth .022" 20 Brackets 3 w. ...

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·August 10, 2007

    ENVAN HEART RATE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMBRYON GIFT TRANSFER CATHETERS/SETS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code ---·June 29, 2007

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·January 19, 2007

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·January 19, 2007

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·June 4, 2007

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 16, 2013

    PATIENT WARMING SYSTEM

    FDA Adverse Event
    KIMBERLY CLARK·Product code DWJ·June 5, 2008

    OUTBACK RE-ENTRY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQY·April 18, 2011

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·January 26, 2007

    PURACOL PLUS COLLAGEN WOUND DRESSING

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, LP·Product code KGN·April 16, 2026

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·February 2, 2007

    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