BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Patient Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VACUTAINER® PLUS BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 15, 2022

    UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANN BLUNT TIP SCREW 4X38MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 20, 2024

    MEDTRONIC LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·October 26, 2018

    BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 4, 2022

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·June 21, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 28, 2011

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    FDA Adverse Event
    Malfunction ·NORTH HAVEN - USS·Product code LFL·September 26, 2008

    PROXIMAL HUMERUS, LEFT, LONG, ÿ 8.5X220MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·June 20, 2024

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021