BEUDAMED
    34 results · 13ms · Sources: EU EUDAMED, US FDA

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    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

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Enforcement
    Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

    INVUITY(R) PhotonBlade(TM), REF PB1

    FDA Recall
    Terminated ·Invuity, Inc.·Product code GEI·June 12, 2017

    INVUITY(R) PhotonBlade(TM), REF PB1

    FDA Enforcement
    Class II ·Terminated·Invuity, Inc.·August 2, 2017

    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

    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code GBQ·June 29, 2015

    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    SS 4.5MM Pellet Insertion Tray Catalog Number: B9807

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    3.2MM Pellet Insertion Tray Catalog Number: B1144

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022

    3.2MM Pellet Insertion Tray Catalog Number: B9743

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FBQ·February 22, 2022