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

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    Filters FDA Enforcement × Classification: Class Iii × 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

    Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.

    FDA Enforcement
    Class III ·Terminated·Berchtold Corp.·August 15, 2012

    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036

    FDA Enforcement
    Class III ·Terminated·Xintec Corp·October 30, 2019

    OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

    FDA Enforcement
    Class III ·Terminated·OrthoPediatrics Corp·December 28, 2016

    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

    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

    FDA Enforcement
    Class III ·Terminated·Integra LifeSciences Corp.·March 18, 2020

    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

    CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. This is an uncemented prosthesis designed for press fit use only.

    FDA Enforcement
    Class III ·Terminated·Integra LifeSciences Corp.·July 3, 2013