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

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    PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE

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

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481113659·LOCATOR R-Tx Abutment for iSy Connection Implan...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114632·LOCATOR F-Tx Abutment for iSy Connection Implan...

    EARGO

    FDA UDI
    Eargo, Inc.·00850010429113·EARGO Replacement Flexi Palm, Size Regular

    TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TRIFUSE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL·Product code FMG·October 3, 2017

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·April 5, 2019

    NA

    FDA UDI
    Zimmer, Inc.·00889024065901·

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·March 17, 2016

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·April 26, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2011

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·June 5, 2019

    EXTRACTION SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·March 19, 2014

    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.

    FDA Enforcement
    Class I ·Terminated·Fresenius Medical Care Holdings, Inc.·July 4, 2012

    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·March 29, 2012

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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