BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    HEARTSTRING III PROXIMAL SEAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019

    ArgenZ HT+ 98x20 ML D2B

    FDA UDI
    ARGEN CORPORATION, THE·D818130382·Dental porcelain/ceramic restoration kit

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925013858·JORDAN OVAL KNIFE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450435434·

    BD PHOENIX¿ PMIC/ID-107

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 23, 2023

    BD PHOENIX¿ PMIC/ID-107

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 23, 2023

    BD PHOENIX¿ PMIC/ID-107

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 23, 2023

    BD PHOENIX¿ PMIC/ID-107

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 23, 2023

    BD PHOENIX¿ PMIC/ID-107

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·January 23, 2023

    SELITHERM, MODEL C100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 1, 2024

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 24, 2013

    9FR J FEED/GASTRIC DEPR TUBE

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code KNT·September 30, 2014

    3.5FR URETHANE UMB CATH

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FOS·May 9, 2011

    Core Biopsy Tray Catalog Number: 8673R4

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012