BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    FUJIFILM Endoscope Model EG-530N

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304272125·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304472884·

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

    STAR 50 N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

    FDA Adverse Event
    Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code JGS·July 22, 2011

    M2A-38 CUP NON FLARED SIZE 52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 22, 2013

    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