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

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    STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REDI-SCREEN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    S4C POLYAXIAL SCREW 3.5X12MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code MNI·May 1, 2009

    5CM HEAVY DUTY SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 24, 2013

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER·Product code JWH·April 13, 2011

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·July 22, 2008

    INDUCTIGRAFT

    FDA Adverse Event
    Injury ·BAXTER APATECH LTD·Product code MQV·January 16, 2014

    INDUCTIGRAFT

    FDA Adverse Event
    Injury ·BAXTER APATECH LTD·Product code MQV·June 10, 2013

    INDUCTIGRAFT

    FDA Adverse Event
    Injury ·BAXTER APATECH LTD·Product code MQV·February 16, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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