BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    WAKO AUTOMATED REAGENTS FOR HITACHI 705

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYSTEMP.CEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CD HORIZON Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALCOSENSOR III AND IV

    FDA Adverse Event
    Death ·INTOXIMETERS, INC.·Product code DJZ·May 11, 1998

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 21, 2012

    ARIS TRANS-OBTURATOR

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FTL·August 21, 2013

    BIOLOX DELTA HEAD, 12/14, 36 X 0

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·September 16, 2010

    INNOVA SELF-EXPANDING STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIP·February 8, 2018

    TRAILBLAZER

    FDA Adverse Event
    Injury ·COVIDIEN·Product code DQY·February 13, 2018

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 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