BEUDAMED
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    Prosthetic Driver KIT

    FDA UDI
    Izenimplant Co., Ltd.·08800070224403·

    Flex-Neck®

    FDA UDI
    Merit Medical Systems, Inc.·00884450104484·

    Flex-Neck®

    FDA UDI
    Merit Medical Systems, Inc.·00884450104682·

    KIT PERISAFE 18GA 3-1/2IN WEISS

    FDA Adverse Event
    Malfunction ·Product code CAZ·June 18, 2020

    EPIDURAL CATHETERIZATION SET NRFIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code BSO·February 12, 2020

    EPIDURAL CATHETERIZATION SET NRFIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code BSO·February 12, 2020

    BARD ACCESS SYSTEMS

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS·Product code MPB·April 5, 2001

    INJECTOMAT MC AGILIA D

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S.·Product code FRN·April 4, 2025

    INJECTOMAT MC AGILIA D

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S.·Product code FRN·April 4, 2025

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC.·Product code NDN·February 26, 2010

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code CAZ·December 11, 2019

    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.

    FDA Enforcement
    Class II ·Terminated·Insulet Corporation·November 13, 2013

    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.

    FDA Recall
    Terminated ·Insulet Corporation·Product code LZG·September 27, 2013

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code OGE·May 13, 2019

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·November 19, 2014

    INJECTOMAT MC AGILIA D

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S·Product code FRN·March 27, 2025

    INJECTOMAT MC AGILIA D

    FDA Adverse Event
    Malfunction ·FRESENIUS VIAL S.A.S·Product code FRN·March 27, 2025

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code CAZ·December 11, 2019

    Cream For X-Ray Attenuation

    FDA classification
    FDA Class 2 ·Cream For X-Ray Attenuation

    ADKING

    FDA UDI
    ShenZhen GoodlyMed Technology Co.,Ltd.·06977239080025·