BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    EMS I.V. START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NuVasive PEEK Corpectomy System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REVOLIX AND REVOLIX JR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIBERTY POSTERIOR SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·July 29, 2014

    EQUINOXE CAGE GLENOID M, POST AUG, LEFT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·October 2, 2024

    GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON SARL·Product code OTP·July 29, 2015

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 22, 2014

    ALTERNATE BEARING METAL LINER 28MM I.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 6, 2011

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024