BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    VAMP Venous/Arterial Blood Management Protection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IOS FASTSCAN SPRAY

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 15, 2014

    1.1MM THREADED GUIDE WIRE 150MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code FZX·June 17, 2013

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 23, 2011

    NV EHXL ALIP LNR G4 36MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 18, 2022

    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