BEUDAMED
    7 results · 28ms · 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 ×

    HDL CHOLESTEROL REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA

    FDA 510(k)
    FDA Class 2 ·Radiology

    NvisionVLE Low-profile Optical Probe

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    TRIGEN

    FDA Adverse Event
    Injury ·SMITH-NEPHEW INC.·Product code LXH·November 4, 2010

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 31, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014