BEUDAMED
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    SURGIDEK

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

    SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741100833·SureStep™ Foley Tray System Bard® Lubri-Sil® Fo...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550216·GENUMEDI PT KNEE SUP SILVER R EW VI

    Bard® Urine Meter Foley Tray With Lubri-Sil® All-Silicone Foley Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741024955·Bard® Urine Meter Foley Tray With Lubri-Sil® Al...

    CADSTREAM VERSION 4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Assurance Alar / Nasal SpO2 Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

    FDA Enforcement
    Class II ·Ongoing·C.R. Bard Inc·September 29, 2021

    REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HTD·July 29, 2014

    HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 5, 2013

    INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105"

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SHERBROOKE·Product code FPA·December 30, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 18, 2014

    Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

    FDA Recall
    Open, Classified ·C.R. Bard Inc·Product code EZL·August 5, 2021

    SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter

    FDA Recall
    Terminated ·Bard Medical Division·Product code MJC·December 13, 2018

    SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter

    FDA Enforcement
    Class II ·Terminated·Bard Medical Division·February 13, 2019