BEUDAMED
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    CHROMIC CATGUT

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

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

    FDA UDI
    C. R. Bard, Inc.·00801741100840·SureStep™ Foley Tray System Bard® Lubri-Sil® Fo...

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

    FDA UDI
    C. R. Bard, Inc.·00801741024962·Bard® Urine Meter Foley Tray With Lubri-Sil® Al...

    ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Penumbra Smart Coil

    FDA 510(k)
    FDA Class 2 ·Neurology

    ZIMMER TRABECULAR METAL GLENOSPHERE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HSD·January 21, 2013

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·December 30, 2010

    UV FLASH TRANSFER SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 18, 2014

    PFNA-II BLADE L95 TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·April 25, 2019

    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