BEUDAMED
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    PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018258·Wide Jaw Punch small 3.5mm 15 degree down

    AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO THE MAESTRO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 10, 2011

    POWER PROCESSOR

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code JJE·August 14, 2008

    I.V. Start Kit Catalog 8172

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    GALAXY G3 6MM X 20CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 XSFT 3MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 8MM X 24CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 7MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 6MM X 10CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    GALAXY G3 6MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022

    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