BEUDAMED
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    H55 HYDROPHILIC CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550131·GENUMEDI PT KNEE SUP SILVER L EW IV

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

    FDA UDI
    C. R. Bard, Inc.·00801741074103·SureStep® Foley Tray System Bard® Lubri-Sil® Fo...

    SureStep Foley Tray System

    FDA UDI
    C. R. Bard, Inc.·00801741218873·SureStep Foley Tray Kit optimized for Sensica U...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094185737·Single Use Ear Tips for OAE Hearing Screener an...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094185744·Single Use Ear Tips for OAE Hearing Screener an...

    POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sonu

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY

    FDA Adverse Event
    Malfunction ·C. R. BARD, INC·Product code EZL·October 22, 2018

    EXTENSION SET 30IN

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code FPA·June 3, 2009

    APM/AIM PUMP SET W/C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·September 28, 2010

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 3, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP·Product code LZG·December 21, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 17, 2014

    BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·December 9, 2024

    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