BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARAMAX MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FLEXIFLO-III PORTABLE ENTERAL NUTRI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION,·Product code MKJ·March 12, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 1, 2012

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 23, 2010

    AIA-PACK TPOAb CONTROL SET

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·June 7, 2017

    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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015