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

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    ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20238401·Steel arches Straight-Arch-F. mand. .016"x.022"

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·August 23, 2019

    MICROJET CRONO PAR AND CRONO APO-GO

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES

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

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 19, 2018

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·March 27, 2013

    INFANT TNCHOFF 2 CUFF

    FDA Adverse Event
    Injury ·COVIDIEN·Product code FJS·March 14, 2011

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·April 2, 2008

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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