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

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    Filters Classification: Class Iii ×

    POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.

    FDA Enforcement
    Class III ·Terminated·Access Scientific LLC·July 22, 2020

    C10-4ec Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025