BEUDAMED
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    ORTHOLOC 3DI HALLUX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017503·Hook Punch set down 2.7mm 7 degree up

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017510·Hook Punch set down 3.5mm 7 degree up

    ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DARCO HEADED CANNULATED SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970515·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970522·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973127·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973554·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973011·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970539·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973417·

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 20, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 10, 2011

    CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENEWAL TR model H120 = 359, model H125 = 235; TR2 model H140 = 613, model H145 = 390.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NKE·June 24, 2006

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015