BEUDAMED
    27 results · 25ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·March 23, 2022

    Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc·June 3, 2020

    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·April 24, 2019

    BostonSight PROSE Lens.

    FDA Enforcement
    Class II ·Ongoing·Boston Foundation For Sight·August 6, 2025

    BostonSight SCLERAL Lens

    FDA Enforcement
    Class II ·Ongoing·Boston Foundation For Sight·August 6, 2025

    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

    FDA Enforcement
    Class II ·Terminated·Centers For Disease Control and Prevention·July 3, 2024

    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·January 29, 2014

    Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014

    Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·January 29, 2014

    Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

    FDA Enforcement
    Class II ·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·November 19, 2014