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

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    NeuViz 128 Multi-slice CT Scanner System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ProLift Trial

    FDA UDI
    Life Spine, Inc.·00190837087272·

    THE INCOURAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZIRPRIME

    FDA 510(k)
    FDA Class 2 ·Dental

    USP II HUMERAL HEAD 50/19

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code KWS·February 16, 2016

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·AVENT S. DE R.L. DE C.V.·Product code HEB·June 7, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·June 8, 2011

    COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·September 4, 2008

    ENTERPRISE2 4MMX23MM NO TIP

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code NJE·July 13, 2018

    C-QUR MOSAIC

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015

    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

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology