BEUDAMED
    4 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.

    FDA Enforcement
    Class II ·Terminated·Inovo, Inc·December 21, 2016

    PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S

    FDA Enforcement
    Class II ·Terminated·Inovo, Inc·January 31, 2018

    Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.

    FDA Enforcement
    Class II ·Terminated·Inovo, Inc·August 7, 2019

    Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog¿, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.

    FDA Enforcement
    Class II ·Terminated·Novo Nordisk Inc·December 13, 2017