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

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    Filters Classification: Class Ii ×

    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

    FDA Enforcement
    Class II ·Terminated·Vascular Solutions, Inc.·September 26, 2012

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics Inc·August 13, 2025