BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    XIDF-AWS801, Angio Workstation, V6.20

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEUSTER

    FDA UDI
    PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI·10810105212089·Sterilization Pouch made of DuPont™ Tyvek® 15,...

    Liner Inserter

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215095932·

    TRIMED RADIOCARPAL FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406

    FDA 510(k)
    FDA Class 2 ·Neurology

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    SYNCHRON® ALKALINE PHOSPHOTASE (ALP)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CJE·July 7, 2011

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code CDZ·September 10, 2008

    VENATECH CONVERTIBLE

    FDA Adverse Event
    Malfunction ·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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