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

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    BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000

    FDA 510(k)
    FDA Unclassified ·Unknown

    Life Spine Lumbar Fixation System (SENTRY)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTP·December 19, 2012

    RIATA PASSIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    OCTRODE 8 PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 15, 2010

    DUAL MOBILITY - UHMWPE

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code LZO·January 29, 2020

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020