BEUDAMED
    42 results · 16ms · Sources: EU EUDAMED, US FDA

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    Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

    FDA Enforcement
    Class III ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 28, 2020

    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·October 9, 2024

    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·May 22, 2024

    RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·May 22, 2024

    RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·May 22, 2024

    RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·May 22, 2024

    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