BEUDAMED
    16 results · 33ms · 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 ×

    NuVasive® Precept™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Voice Control

    FDA UDI
    Aktormed GmbH·04260463848946·

    HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    XEBRA DICOM IMAGE BROWSER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLM A+ PLATINUM MODU

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 7, 2013

    NONE

    FDA Adverse Event
    Death ·Product code MKJ·March 28, 2006

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

    SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894

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

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 4, 2019

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 4, 2019

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·Product code DQX·May 21, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·December 28, 2021

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 17, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·October 3, 2023

    APPROACH CTO MICROWIRE WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·October 31, 2023

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021