BEUDAMED
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    THE AUTOTAC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011201·Zirlux 16+ A3 95X10

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·January 29, 2021

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033319789·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033319772·

    ENSIL FABRIC

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EASYBELL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·April 24, 2025

    LINER: CC E CC LIGHT 01.26.3644HCT FLAT PE HC LINER 36 / E

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 3, 2021

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IKX·March 19, 2013

    SPEEDSCREW 5.5 MM KNOTLESS FIXATION DEVICE

    FDA Adverse Event
    Other ·ARTHROCARE CORP·Product code HWC·March 1, 2011

    GREENFIELD 12FR SS VENA CAVA FILTER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DTK·March 10, 2008

    Hernia Pack, part number AMS3859

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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