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

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    STARLIGHT

    FDA 510(k)
    FDA Class 2 ·Neurology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450210369·

    SHUTTLE STOP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACTIVEECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 19, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 15, 2014

    Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·October 25, 2010

    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 6, 2016

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015