BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERDICT -II BAR/BZO

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    MESH, SURGICAL

    FDA Adverse Event
    Injury ·W. L. GORE AND ASSOCIATES, INC.·Product code FTM·August 12, 2023

    BD¿ PRN ADAPTER

    FDA Adverse Event
    Malfunction ·Product code FPA·October 1, 2021

    S-ROM*SLEEVE PRX ZTT, 14D-SML

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code LPH·April 22, 2013

    PELORIS RAPID TISSUE PROCESSOR

    FDA Adverse Event
    Malfunction ·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·April 8, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 2, 2008

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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