BEUDAMED
    17 results · 17ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Ongoing × Clear all

    Cardiosave Hybrid

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·December 24, 2025

    Cardiosave Rescue

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·December 24, 2025

    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

    FDA Enforcement
    Class III ·Ongoing·Preat Corp·March 15, 2023

    Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·July 6, 2022

    Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·July 6, 2022

    Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·May 5, 2021

    Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·May 5, 2021

    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·April 20, 2022

    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·June 21, 2023

    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

    FDA Enforcement
    Class III ·Ongoing·Volcano Corp·April 20, 2022

    Battery Charging Station; Model: 0998-00-0802;

    FDA Enforcement
    Class III ·Ongoing·Datascope Corp.·March 25, 2026

    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

    FDA Enforcement
    Class III ·Ongoing·Howmedica Osteonics Corp.·December 28, 2022

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    FDA Enforcement
    Class III ·Ongoing·Howmedica Osteonics Corp.·December 28, 2022

    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·December 4, 2019

    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·December 4, 2019

    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·November 13, 2019

    FloPatch FP120, REF: FP120-FOT01-005

    FDA Enforcement
    Class III ·Ongoing·Flosonics Medical (R/A 1929803 ONTARIO CORP.)·September 10, 2025