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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Terminated × Clear all

    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

    FDA Enforcement
    Class II ·Terminated·NOVADAQ TECHNOLOGIES INC.·October 4, 2017

    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.

    FDA Enforcement
    Class II ·Terminated·NOVADAQ TECHNOLOGIES INC.·September 14, 2016

    OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018

    OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G

    FDA Enforcement
    Class II ·Terminated·AROA Biosurgery, LTD.·November 21, 2018