BEUDAMED
    7 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·July 4, 2018

    (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

    FDA Enforcement
    Class II ·Terminated·BSN Medical Inc·June 15, 2022

    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014

    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014

    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

    FDA Enforcement
    Class II ·Terminated·Genesis BPS, LLC.·September 24, 2014