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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    CEI Cutting Edge Instruments (PTC-57C)

    FDA Enforcement
    Class II ·Ongoing·Coltene Whaledent Inc·November 25, 2020

    MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

    FDA Enforcement
    Class II ·Terminated·Microgenics Corporation·December 10, 2014

    D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 3, 2015

    Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

    FDA Enforcement
    Class II ·Ongoing·Synthes (USA) Products LLC·October 12, 2022

    PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

    FDA Enforcement
    Class II ·Terminated·TEI Biosciences·January 24, 2018

    PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Enforcement
    Class II ·Terminated·Ceg Enterprises Llc·June 29, 2016

    PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023