BEUDAMED
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    Arrow Endurance Extended Dwell Peripheral Catheter System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HairCheck-DT (Cocaine)

    FDA UDI
    Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

    STRAUMANN COMPUTER AIDED RESTORATION SERVICE

    FDA 510(k)
    FDA Class 2 ·Dental

    EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013

    PERCUNAV

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code JAK·June 23, 2011

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 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