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

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    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black

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

    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

    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

    Unloader Custom Lite Product Usage: Unloader Custom Lite 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

    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

    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

    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

    Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom 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

    Extreme Custom Product Usage: Extreme 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

    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

    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

    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

    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

    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22, 23 and 24. The system is not intended for athletic use.

    FDA Recall
    Terminated ·Ossur Americas, Inc.·October 15, 2012

    OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

    FDA Recall
    Terminated ·Ossur Americas·Product code ISH·May 30, 2022

    Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

    FDA Recall
    Terminated ·Ossur Americas·Product code HAX·June 21, 2018

    Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool

    FDA Recall
    Terminated ·Ossur Americas·Product code KQZ·June 21, 2018

    Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

    FDA Recall
    Terminated ·Ossur Americas·Product code IQK·November 9, 2021

    Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX

    FDA Recall
    Terminated ·Ossur Americas·Product code KQZ·June 21, 2018