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

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    UNISTEP HCG PREGNANCY TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112359·SURG-I-BAND PURPLE GLOW

    HDL-EX SEIKEN ASSAY KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·January 31, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 8, 2010

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Other ·MERZ NORTH AMERICA·Product code LMH·July 7, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017