BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Doctor Nice

    FDA UDI
    B. Ali Impex·08964003163815·Forceps, Adson Dressing, item 14-1353-12, 4-5/8”

    GOLDEN GATE ANTERIOR PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·June 3, 2013

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 1, 2011

    3F STONE BASKET

    FDA Adverse Event
    Other ·APPLIED MEDICAL RESOURCES·Product code FFL·August 28, 2008

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019