BEUDAMED
    30 results · 7ms · Sources: EU EUDAMED, US FDA

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

    Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.

    FDA Enforcement
    Class II ·Terminated·Fenwal Inc·May 1, 2019

    Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019

    SurFlo IV Catheter

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corporation·May 10, 2017

    Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·March 25, 2015

    Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 27, 2016

    Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 27, 2016

    Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 1, 2015

    Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 27, 2016

    Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 27, 2016

    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 27, 2016