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

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    ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283495·KLEINERT-KUTZ HOOK 6" 5 MILLIMETER

    Trilogy Circuit

    FDA UDI
    Respironics, Inc.·00606959026131·Trilogy Active with Positive Airway Pressure (P...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809849370·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE FU...

    THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROXIS SVG/FLOW CONTROL, 7F LONG SHEATH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code NFA·July 31, 2008

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS LLC·Product code OYC·November 28, 2018

    *

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·March 29, 2013

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·March 1, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 20, 2008

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

    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