BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    CEDIA(R) DIGOXIN SC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756366205·RETINA PACK

    PLEURX PLEURAL CATHETER AND DRAINAGE KITS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SILJETR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MEMBRAGEL

    FDA Adverse Event
    Injury ·BIORA AB·Product code NPK·November 19, 2010

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 4, 2012

    ACCU-CHEK ® INFORM II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 2, 2014

    icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·April 24, 2019