BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    HF1202H PowerPlus Portable X-ray Equipment

    FDA 510(k)
    FDA Class 2 ·Radiology

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172971185·

    TROPHON

    FDA 510(k)
    FDA Class 2 ·Radiology

    ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 31, 2024

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    ENDURANT STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·June 29, 2011

    PFC SIGMA C/R NPOR FEM LT SZ 3

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·September 5, 2008

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 4, 2023

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

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

    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