BEUDAMED
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    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Recall
    Terminated ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code PGQ·October 16, 2018

    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Recall
    Terminated ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code PGQ·October 16, 2018

    MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Recall
    Terminated ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code PGQ·October 16, 2018

    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 Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code IZI·August 18, 2016

    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

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0

    FDA Recall
    Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code NEY·April 17, 2019

    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 Recall
    Terminated ·NOVADAQ TECHNOLOGIES INC.·Product code MMP·June 27, 2017

    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