BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    VISTA STREAK RETINOSCOPE (AC-POWERED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VIAMO SSA-640A VERSION 1.2

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROCEDURE & RECOVERY PATIENT SUIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 25, 2014

    OXFORD ANATOMIC BEARING

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·October 29, 2010

    ALARIS PCA MODULE

    FDA Adverse Event
    Death ·CAREFUSION CORPORATION·Product code FRN·December 19, 2012

    ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

    ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

    ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

    ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

    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