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

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    THEOPHYLLINE (FPIA) CALIBRATOR KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MP-1 MICROPERIMETER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LUCAS 3 Chest Compression System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·December 7, 2012

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    LUCAS 3 CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Death ·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

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