BEUDAMED
    22 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    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

    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

    FDA Enforcement
    Class II ·Terminated·AcuFocus, Inc.·March 30, 2016

    The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.

    FDA Enforcement
    Class II ·Terminated·AccessClosure, Inc., A Cardinal Health Company·November 2, 2016

    PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, partial thickness burns, ulcers (such as Diabetic, pressure, or venous insufficiency), flaps and grafts. When used on closed surgical incisions they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. All exudates and infectious materials are collected in the canister

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·June 7, 2017

    PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·March 12, 2014

    ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·July 15, 2020

    BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.

    FDA Enforcement
    Class II ·Terminated·KCI USA, Inc.·October 3, 2012

    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

    FDA Enforcement
    Class II ·Terminated·KCI USA, Inc.·November 28, 2012

    CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

    FDA Enforcement
    Class II ·Terminated·KCI USA, Inc.·October 8, 2014

    V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.

    FDA Enforcement
    Class II ·Terminated·KCI USA, Inc.·October 22, 2014

    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·January 14, 2015

    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.

    FDA Enforcement
    Class II ·Terminated·KCI USA, INC.·January 13, 2016

    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014