BEUDAMED
    9 results · 20ms · 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.
    Filters Regulation: Us FDA ×

    PrisMax System Version 3

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

    JOURNEY II DEEP DISHED ARTICULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REFLOW ASPIRATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVIS EXERA III DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·February 18, 2022

    AGC V2 POROUS TIB 83 X 10MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·June 8, 2021

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 7, 2008

    LINOX SMART SD 65/18

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·June 27, 2013

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·July 13, 2011

    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