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

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    Filters Classification: Class Ii ×

    e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·November 11, 2015

    Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 21, 2018