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

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    Affirm Prone Biopsy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRIATHLON P/A CR BEADED #5L

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 8, 2013

    INSTATRAK 3500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·June 21, 2011

    MASIMO

    FDA Adverse Event
    Malfunction ·MASIMO CORP·Product code DQA·September 8, 2008

    TRIATHION

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    TRIATHION COMPONENT

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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